Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00048542 | Arthritis, Juvenile | Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase Week 16 to Week 48 (32 weeks) | Double-Blind Adalimumab | 13 Participants |
| Double-Blind Placebo | 20 Participants | |||
| NCT00055497 CLASSICII | Crohn Disease | Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF) Week 56 | DB Adalimumab 40 mg Every Other Week (Eow) | 15 Participants |
| DB Adalimumab 40 mg Every Week (ew) | 15 Participants | |||
| DB Placebo | 8 Participants | |||
| NCT00055497 CLASSICII | Crohn Disease | Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) Week 56 | DB Adalimumab 40 mg Every Other Week (Eow) | 9 Participants |
| DB Adalimumab 40 mg Every Week (ew) | 12 Participants | |||
| Placebo | 6 Participants | |||
| NCT00085644 ATLAS | Spondylitis, Ankylosing | Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score Week 104 | Any Adalimumab | 0.9 score on a scale (±0.19 Standard Error) |
| Any Adalimumab | 0.9 score on a scale (±0.23 Standard Error) | |||
| NCT00085644 ATLAS | Spondylitis, Ankylosing | Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). Week 12 | Adalimumab | 83 Participants (responders, nonresponders) |
| Adalimumab | 121 Participants (responders, nonresponders) | |||
| Adalimumab | 4 Participants (responders, nonresponders) | |||
| Placebo | 22 Participants (responders, nonresponders) | |||
| Placebo | 3 Participants (responders, nonresponders) | |||
| Placebo | 82 Participants (responders, nonresponders) | |||
| NCT00195650 | Arthritis, Rheumatoid | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260 Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260 | Adalimumab | -0.59 units on a scale (±0.628 Standard Deviation) |
| NCT00195650 | Arthritis, Rheumatoid | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520 Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520 | Adalimumab | -0.52 units on a scale (±0.662 Standard Deviation) |
| NCT00195650 | Arthritis, Rheumatoid | Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260 Week 260 | Adalimumab | 243 participants |
| NCT00195650 | Arthritis, Rheumatoid | Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520 Week 520 | Adalimumab | 135 participants |
| NCT00195650 | Arthritis, Rheumatoid | Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260 Week 260 | Adalimumab | 402 participants |
| NCT00195650 | Arthritis, Rheumatoid | Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520 Week 520 | Adalimumab | 187 participants |
| NCT00195650 | Arthritis, Rheumatoid | Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260 Week 260 | Adalimumab | 279 participants |
| NCT00195650 | Arthritis, Rheumatoid | Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520 Week 520 | Adalimumab | 132 participants |
| NCT00195650 | Arthritis, Rheumatoid | Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260 Week 260 | Adalimumab | 179 participants |
| NCT00195650 | Arthritis, Rheumatoid | Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520 Week 520 | Adalimumab | 78 participants |
| NCT00195663 PREMIER | Arthritis, Rheumatoid | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 Baseline and Week 52 | Adalimumab | 3.0 units on a scale (±11.2 Standard Deviation) |
| Adalimumab + Methotrexate | 1.3 units on a scale (±6.5 Standard Deviation) | |||
| Methotrexate | 5.7 units on a scale (±12.7 Standard Deviation) | |||
| NCT00195663 PREMIER | Arthritis, Rheumatoid | Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 Baseline and 52 Weeks | Adalimumab | 113 participants |
| Adalimumab + Methotrexate | 165 participants | |||
| Methotrexate | 118 participants | |||
| NCT00195676 | Psoriasis | Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R Week 16 of Period R | Period R Modified Intent-to-Treat Population | 76.5 percentage of participants |
| NCT00195702 | Arthritis, Rheumatoid | Change From Baseline in Modified Total Sharp X-ray Score at Week 52 Baseline and Week 52 | DB Adalimumab 20 mg ew | 0.8 Units on a scale (±4.9 Standard Deviation) |
| DB Adalimumab 40 mg Eow | 0.1 Units on a scale (±4.8 Standard Deviation) | |||
| DB Placebo ew | 2.7 Units on a scale (±6.8 Standard Deviation) | |||
| NCT00195702 | Arthritis, Rheumatoid | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52 Baseline and Week 52 | DB Adalimumab 20 mg ew | -0.61 Units on a scale (±0.55 Standard Deviation) |
| DB Adalimumab 40 mg Eow | -0.59 Units on a scale (±0.57 Standard Deviation) | |||
| DB Placebo ew | -0.25 Units on a scale (±0.56 Standard Deviation) | |||
| NCT00195702 | Arthritis, Rheumatoid | Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24 Week 24 | DB Adalimumab 20 mg ew | 129 Participants |
| DB Adalimumab 40 mg Eow | 131 Participants | |||
| DB Placebo ew | 59 Participants | |||
| NCT00195715 | Crohn Disease | Percentage of Subjects Achieving Clinical Remission Week 156 | Open-label Adalimumab | 69.5 Percentage of participants |
| Open-label Adalimumab | 46.7 Percentage of participants | |||
| Open-label Adalimumab | 68.8 Percentage of participants | |||
| Open-label Adalimumab | 59.4 Percentage of participants | |||
| NCT00195819 | Spondylitis, Ankylosing | Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score Baseline and Week 104 | Any Adalimumab | 0.5 score on a scale (±0.36 Standard Error) |
| Any Adalimumab | 0.9 score on a scale (±0.23 Standard Error) | |||
| NCT00195819 | Spondylitis, Ankylosing | Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 Week 12 | Adalimumab | 20 participants |
| Adalimumab | 0 participants | |||
| Adalimumab | 18 participants | |||
| Placebo | 0 participants | |||
| Placebo | 12 participants | |||
| Placebo | 32 participants | |||
| NCT00235872 | Arthritis, Rheumatoid | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) | Adalimumab 40 mg Eow | 155 participants |
| Adalimumab 40 mg Eow | 58 participants | |||
| Adalimumab 40 mg Eow | 104 participants | |||
| Adalimumab 40 mg Eow | 166 participants | |||
| Adalimumab 40 mg Eow | 0 participants | |||
| Adalimumab 40 mg Eow | 1 participants | |||
| Adalimumab 40 mg Eow | 1 participants | |||
| Adalimumab 40 mg Eow | 4 participants | |||
| Adalimumab 40 mg Eow | 7 participants | |||
| Adalimumab 40 mg Eow | 8 participants | |||
| Adalimumab 40 mg Eow | 8 participants | |||
| Adalimumab 40 mg Eow | 16 participants | |||
| Adalimumab 40 mg Eow | 24 participants | |||
| Adalimumab 40 mg Eow | 16 participants | |||
| Adalimumab 40 mg Eow | 33 participants | |||
| Adalimumab 40 mg Eow | 47 participants | |||
| Adalimumab 40 mg Eow | 28 participants | |||
| Adalimumab 40 mg Eow | 42 participants | |||
| Adalimumab 40 mg Eow | 27 participants | |||
| Adalimumab 40 mg Eow | 47 participants | |||
| Adalimumab 40 mg Eow | 25 participants | |||
| Adalimumab 40 mg Eow | 47 participants | |||
| Adalimumab 40 mg Eow | 63 participants | |||
| Adalimumab 40 mg Eow | 27 participants | |||
| Adalimumab 40 mg Eow | 49 participants | |||
| Adalimumab 40 mg Eow | 68 participants | |||
| Adalimumab 40 mg Eow | 23 participants | |||
| Adalimumab 40 mg Eow | 41 participants | |||
| Adalimumab 40 mg Eow | 63 participants | |||
| Adalimumab 40 mg Eow | 43 participants | |||
| Adalimumab 40 mg Eow | 72 participants | |||
| Adalimumab 40 mg Eow | 27 participants | |||
| Adalimumab 40 mg Eow | 61 participants | |||
| Adalimumab 40 mg Eow | 62 participants | |||
| Adalimumab 40 mg Eow | 104 participants | |||
| Adalimumab 40 mg Eow | 22 participants | |||
| Adalimumab 40 mg Eow | 157 participants | |||
| Adalimumab 40 mg Eow | 74 participants | |||
| Adalimumab 40 mg Eow | 30 participants | |||
| Adalimumab 40 mg Eow | 154 participants | |||
| Adalimumab 40 mg Eow | 74 participants | |||
| Adalimumab 40 mg Eow | 40 participants | |||
| Adalimumab 40 mg Eow | 154 participants | |||
| Adalimumab 40 mg Eow | 83 participants | |||
| Adalimumab 40 mg Eow | 39 participants | |||
| Adalimumab 40 mg Eow | 148 participants | |||
| Adalimumab 40 mg Eow | 81 participants | |||
| Adalimumab 40 mg Eow | 46 participants | |||
| Adalimumab 40 mg Eow | 155 participants | |||
| Adalimumab 40 mg Eow | 77 participants | |||
| Adalimumab 40 mg Eow | 46 participants | |||
| Adalimumab 40 mg Eow | 91 participants | |||
| Adalimumab 40 mg Eow | 49 participants | |||
| Adalimumab 40 mg Eow | 81 participants | |||
| Adalimumab 40 mg Eow | 33 participants | |||
| Adalimumab 40 mg Eow | 63 participants | |||
| Adalimumab 40 mg Eow | 92 participants | |||
| Adalimumab 40 mg Eow | 45 participants | |||
| Adalimumab 40 mg Eow | 75 participants | |||
| Adalimumab 40 mg Eow | 118 participants | |||
| Adalimumab 40 mg Eow | 47 participants | |||
| Adalimumab 40 mg Eow | 86 participants | |||
| Adalimumab 40 mg Eow | 141 participants | |||
| Adalimumab 40 mg Eow | 52 participants | |||
| Adalimumab 40 mg Eow | 99 participants | |||
| Adalimumab 40 mg Eow | 158 participants | |||
| Adalimumab 40 mg Eow | 50 participants | |||
| Adalimumab 40 mg Eow | 99 participants | |||
| Adalimumab 40 mg Eow | 163 participants | |||
| Adalimumab 40 mg Eow | 46 participants | |||
| Adalimumab 40 mg Eow | 52 participants | |||
| Adalimumab 40 mg Eow | 24 participants | |||
| NCT00348283 | Crohn Disease | Number of Subjects Without Mucosal Ulceration at Week 12 Week 12 | Adalimumab | 17 Subjects |
| Placebo | 8 Subjects | |||
| NCT00385736 | Colitis, Ulcerative | Proportion of Participants With Clinical Remission Per Mayo Score at Week 8 Week 8 | Adalimumab 160/80/40 | 18.5 Proportion of participants |
| Adalimumab 80/40 | 10.0 Proportion of participants | |||
| Placebo | 9.2 Proportion of participants | |||
| NCT00408629 | Colitis, Ulcerative | Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52 Week 52 | Adalimumab 160/80/40 | 17.3 Percentage of Participants |
| Placebo | 8.5 Percentage of Participants | |||
| NCT00408629 | Colitis, Ulcerative | Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8 Week 8 | Adalimumab 160/80/40 | 16.5 Percentage of Participants |
| Placebo | 9.3 Percentage of Participants | |||
| NCT00409617 | Crohn Disease | Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5. Week 20 of treatment | Open Label Adalimumab 40 mg Every Other Week or Every Week | 492 Participants |
| NCT00409682 | Crohn Disease | Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26 Week 26 | High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52) | 38.7 percent of participants |
| Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) | 28.4 percent of participants | |||
| NCT00427921 ACCESS | Crohn Disease | Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections. Up to 24 weeks | 40 mg Adalimumab Every Other Week | 98.85 Percentage of injections (±4.207 Standard Deviation) |
| NCT00427921 ACCESS | Crohn Disease | Mean Extent of Exposure - Duration in Days Up to 24 weeks | 40 mg Adalimumab Every Other Week | 159.2 days (±34.78 Standard Deviation) |
| NCT00427921 ACCESS | Crohn Disease | Total Number of Injections of Adalimumab Up to 24 weeks | 40 mg Adalimumab Every Other Week | 2 injections (±0.1 Standard Deviation) |
| 40 mg Adalimumab Every Other Week | 11.8 injections (±4.24 Standard Deviation) | |||
| NCT00445432 | Crohn Disease | Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment Week 52 of double-blind treatment | DB Adalimumab 40 mg Eow | 8 Participants |
| Placebo Eow | 2 Participants | |||
| NCT00445939 | Crohn Disease | The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 4 Weeks | Adalimumab 160 mg/80 mg | 11 Particpants |
| Adalimumab 80 mg/40 mg | 6 Particpants | |||
| Placebo | 3 Particpants | |||
| NCT00513370 PRIDE | Psoriasis | Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks 16 weeks | Adalimumab 40 mg Eow - 16 Weeks | 144 participants |
| Adalimumab 40 mg Eow - 16 Weeks | 47 participants | |||
| NCT00538902 | Arthritis, Rheumatoid | Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period Week 12 | Adalimumab 40 mg | 69 Participants |
| Adalimumab 80 mg | 62 Participants | |||
| Placebo | 21 Participants | |||
| NCT00566722 | Psoriasis | Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16 Week 16 | Sub-optimal Response to Etanercept | 40 Participants |
| Sub-optimal Response to MTX | 25 Participants | |||
| Sub-optimal Response to Narrow-band Ultraviolet-B | 14 Participants | |||
| NCT00573794 | Colitis, Ulcerative | Mayo Score: Change From Baseline Over Time Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | Adalimumab 40 mg EOW/EW | 3.5 units on a scale (±2.72 Standard Deviation) |
| Adalimumab 40 mg EOW/EW | -0.5 units on a scale (±2.49 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -0.3 units on a scale (±2.64 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -0.8 units on a scale (±2.73 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -2.0 units on a scale (±1.73 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -1.3 units on a scale (±2.87 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -0.9 units on a scale (±2.84 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -1.0 units on a scale (±2.40 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -0.8 units on a scale (±2.52 Standard Deviation) | |||
| NCT00573794 | Colitis, Ulcerative | Partial Mayo Score: Change From Baseline Over Time Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | Adalimumab 40 mg EOW/EW | -2.0 units on a scale (±1.00 Standard Deviation) |
| Adalimumab 40 mg EOW/EW | -0.6 units on a scale (±1.84 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -0.5 units on a scale (±2.06 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -0.4 units on a scale (±1.78 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -0.2 units on a scale (±2.04 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | 2.5 units on a scale (±2.02 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -1.0 units on a scale (±1.97 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -0.7 units on a scale (±2.05 Standard Deviation) | |||
| Adalimumab 40 mg EOW/EW | -0.8 units on a scale (±1.79 Standard Deviation) | |||
| NCT00574249 BELIEVE | Psoriasis | Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) Week 0 and Week 16 | Adalimumab + Calcipotriol/Betamethasone | 64.8 percentage of participants |
| Adalimumab + Placebo | 70.9 percentage of participants | |||
| NCT00603993 | Arthritis, Rheumatoid | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value) | Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 57 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 35 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 49 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 62 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 3 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 3 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 7 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 16 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 24 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 28 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 29 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 45 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 54 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 27 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 43 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 56 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 29 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 42 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 32 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 47 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 57 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 28 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 44 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 56 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 27 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 46 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 62 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 32 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 45 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 64 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 29 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 48 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 63 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 31 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 49 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 68 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 30 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 49 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 67 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 30 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 50 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 68 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 32 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 45 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 69 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 27 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 44 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 64 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 28 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 48 participants | |||
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | 66 participants | |||
| NCT00647270 | Arthritis, Rheumatoid | The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow) Week 12 | Adalimumab 40 mg Eow | 80 participants |
| Adalimumab 40 mg Eow | 79 participants | |||
| Adalimumab 80 mg Monthly | 97 participants | |||
| Adalimumab 80 mg Monthly | 108 participants | |||
| Placebo | 19 participants | |||
| Placebo | 37 participants | |||
| NCT00647400 | Psoriasis | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab | Adalimumab 40 mg Every Other Week | 80 Participants |
| Adalimumab 40 mg Every Other Week | 78 Participants | |||
| Adalimumab 40 mg Every Other Week | 29 Participants | |||
| Adalimumab 40 mg Every Other Week | 76 Participants | |||
| Adalimumab 40 mg Every Other Week | 80 Participants | |||
| Adalimumab 40 mg Every Other Week | 75 Participants | |||
| Adalimumab 40 mg Every Other Week | 71 Participants | |||
| Adalimumab 40 mg Every Other Week | 79 Participants | |||
| Adalimumab 80 mg Every Other Week | 49 Participants | |||
| Adalimumab 80 mg Every Other Week | 51 Participants | |||
| Adalimumab 80 mg Every Other Week | 52 Participants | |||
| Adalimumab 80 mg Every Other Week | 55 Participants | |||
| Adalimumab 80 mg Every Other Week | 52 Participants | |||
| Adalimumab 80 mg Every Other Week | 54 Participants | |||
| Adalimumab 80 mg Every Other Week | 14 Participants | |||
| Adalimumab 80 mg Every Other Week | 47 Participants | |||
| NCT00667355 | Spondylitis, Ankylosing | Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12 Week 12 | Adalimumab | 30 Subjects |
| Adalimumab | 30 Subjects | |||
| Adalimumab | 30 Subjects | |||
| NCT00686374 | Crohn Disease | Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 | Any Adalimumab | 67 Participants |
| Any Adalimumab | 60 Participants | |||
| Any Adalimumab | 8 Participants | |||
| Any Adalimumab | 14 Participants | |||
| Any Adalimumab | 59 Participants | |||
| Any Adalimumab | 60 Participants | |||
| Any Adalimumab | 54 Participants | |||
| Any Adalimumab | 60 Participants | |||
| Any Adalimumab | 49 Participants | |||
| Any Adalimumab | 54 Participants | |||
| Any Adalimumab | 54 Participants | |||
| Any Adalimumab | 54 Participants | |||
| Any Adalimumab | 52 Participants | |||
| Any Adalimumab | 51 Participants | |||
| Any Adalimumab | 44 Participants | |||
| Any Adalimumab | 44 Participants | |||
| Any Adalimumab | 36 Participants | |||
| Any Adalimumab | 37 Participants | |||
| Any Adalimumab | 31 Participants | |||
| Any Adalimumab | 24 Participants | |||
| Any Adalimumab | 2 Participants | |||
| Any Adalimumab | 7 Participants | |||
| Any Adalimumab | 67 Participants | |||
| Any Adalimumab | 65 Participants | |||
| NCT00686374 | Crohn Disease | Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 | Any Adalimumab | 52 Participants |
| Any Adalimumab | 53 Participants | |||
| Any Adalimumab | 64 Participants | |||
| Any Adalimumab | 65 Participants | |||
| Any Adalimumab | 70 Participants | |||
| Any Adalimumab | 72 Participants | |||
| Any Adalimumab | 95 Participants | |||
| Any Adalimumab | 72 Participants | |||
| Any Adalimumab | 76 Participants | |||
| Any Adalimumab | 87 Participants | |||
| Any Adalimumab | 92 Participants | |||
| Any Adalimumab | 90 Participants | |||
| Any Adalimumab | 35 Participants | |||
| Any Adalimumab | 43 Participants | |||
| Any Adalimumab | 46 Participants | |||
| Any Adalimumab | 69 Participants | |||
| Any Adalimumab | 28 Participants | |||
| Any Adalimumab | 15 Participants | |||
| Any Adalimumab | 10 Participants | |||
| Any Adalimumab | 8 Participants | |||
| Any Adalimumab | 2 Participants | |||
| Any Adalimumab | 74 Participants | |||
| Any Adalimumab | 82 Participants | |||
| Any Adalimumab | 88 Participants | |||
| NCT00690573 | Arthritis, Juvenile | Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 Week 16 | Adalimumab | 23 Participants |
| NCT00775437 | Arthritis, Juvenile | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months). | Adalimumab | 29 participants |
| Adalimumab | 5 participants | |||
| NCT00853099 | Colitis, Ulcerative | Percentage of Participants With Clinical Remission at 52 Weeks Week 52 | Adalimumab 160 mg/80 mg | 20.0 percentage of participants |
| Adalimumab 80 mg/40 mg | 26.4 percentage of participants | |||
| Placebo | 7.3 percentage of participants | |||
| NCT00853099 | Colitis, Ulcerative | Percentage of Participants With Clinical Remission at 8 Weeks Week 8 | Adalimumab 160 mg/80 mg | 10.0 percentage of participants |
| Adalimumab 80 mg/40 mg | 13.8 percentage of participants | |||
| Placebo | 11.5 percentage of participants | |||
| NCT00870467 | Arthritis, Rheumatoid | Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 Baseline, Week 26 | DB Adalimumab | 1.5 units on a scale (±6.07 Standard Deviation) |
| DB Placebo | 2.4 units on a scale (±3.20 Standard Deviation) | |||
| NCT00927069 | — | Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12. 12 weeks | Group B | 11 Participants |
| NCT00929864 | Arthritis, Rheumatoid | The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population Day 1 to Day 365 | Abatacept | 64.8 percentage of participants |
| Adalimumab | 63.4 percentage of participants | |||
| NCT00939003 | Axial Spondyloarthritis | Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response Baseline and Week 12 | Double-blind Adalimumab | 33 participants |
| Double-blind Placebo | 14 participants | |||
| NCT01064856 | — | Number of Participants With Adverse Events Baseline (day of first study drug administration) through Week 156 plus 70 days | Double-blind (DB) Adalimumab | 47 participants |
| Double-blind (DB) Adalimumab | 4 participants | |||
| Double-blind (DB) Adalimumab | 21 participants | |||
| Double-blind (DB) Adalimumab | 3 participants | |||
| Double-blind (DB) Adalimumab | 0 participants | |||
| Double-blind (DB) Adalimumab | 18 participants | |||
| Double-blind (DB) Adalimumab | 1 participants | |||
| Double-blind Placebo | 0 participants | |||
| Double-blind Placebo | 0 participants | |||
| Double-blind Placebo | 24 participants | |||
| Double-blind Placebo | 1 participants | |||
| Double-blind Placebo | 45 participants | |||
| Double-blind Placebo | 15 participants | |||
| Double-blind Placebo | 2 participants | |||
| NCT01064856 | — | Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12 Week 12 | Double-blind (DB) Adalimumab | 60.7 percentage of participants |
| Double-blind (DB) Adalimumab | 39.3 percentage of participants | |||
| Double-blind Placebo | 80.2 percentage of participants | |||
| Double-blind Placebo | 19.8 percentage of participants | |||
| NCT01070303 CLASSICII | Crohn Disease | Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303). Week 104 | Non-Remitters | 71 Participants |
| Remitters | 29 Participants | |||
| NCT01114880 | Spondylitis, Ankylosing | Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria Week 12 | Adalimumab/Adalimumab | 154 participants |
| Placebo/Adalimumab | 35 participants | |||
| NCT01124838 Visual II | Uveitis | Time to Treatment Failure on or After Week 2 From Baseline until end of study (up to 80 weeks) | Integrated Study (Main + Japan Sub-study): Adalimumab | NA months |
| Integrated Study (Main + Japan Sub-study): Placebo | 5.6 months | |||
| Main Study: Adalimumab | NA months | |||
| Main Study: Placebo | 8.3 months | |||
| NCT01138657 VISUAL l | Uveitis | Time to Treatment Failure on or After Week 6 From Baseline until end of study (up to 80 weeks) | Integrated Study (Main + Japan Sub-study): Adalimumab | 4.8 months |
| Integrated Study (Main + Japan Sub-study): Placebo | 3.0 months | |||
| Main Study: Adalimumab | 5.6 months | |||
| Main Study: Placebo | 3.0 months | |||
| NCT01148225 VISUAL III | Uveitis | Chemistry: Number of Participants With PCS Values Baseline to Final Visit (Up to 366 weeks) | Adalimumab | 5 participants |
| Adalimumab | 1 participants | |||
| Adalimumab | 2 participants | |||
| Adalimumab | 2 participants | |||
| Adalimumab | 18 participants | |||
| Adalimumab | 7 participants | |||
| Adalimumab | 4 participants | |||
| Adalimumab | 3 participants | |||
| Adalimumab | 2 participants | |||
| Adalimumab | 8 participants | |||
| Adalimumab | 3 participants | |||
| NCT01148225 VISUAL III | Uveitis | Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit Baseline to Final Visit (Up to 366 weeks) | Adalimumab | 1.443 mmHg (±10.4373 Standard Deviation) |
| Adalimumab | 1.955 mmHg (±14.6281 Standard Deviation) | |||
| NCT01148225 VISUAL III | Uveitis | Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values Baseline to Final Visit (Up to 366 weeks) | Adalimumab | 6 participants |
| Adalimumab | 7 participants | |||
| Adalimumab | 3 participants | |||
| NCT01148225 VISUAL III | Uveitis | Number of Participants With Adverse Events Baseline to Final Visit (up to 366 weeks) | Adalimumab | 398 participants |
| Adalimumab | 101 participants | |||
| NCT01148225 VISUAL III | Uveitis | Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit Baseline to Final Visit (Up to 366 weeks) | Adalimumab | -1.0 beats per minute (±11.92 Standard Deviation) |
| NCT01148225 VISUAL III | Uveitis | Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit Baseline to Final Visit (Up to 366 weeks) | Adalimumab | -0.1 respirations per minute (±2.94 Standard Deviation) |
| NCT01148225 VISUAL III | Uveitis | Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit Baseline to Final Visit (Up to 366 weeks) | Adalimumab | -0.03 Centigrade (±0.516 Standard Deviation) |
| NCT01166282 | Spondylitis, Ankylosing | Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12 Baseline and Week 12 | Double-blind Adalimumab EOW | -62.6 percent change (±59.53 Standard Deviation) |
| Double-blind Placebo EOW | -11.6 percent change (±100.5 Standard Deviation) | |||
| NCT01185301 CONCERTO | Arthritis, Rheumatoid | Percentage of Participants With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) Low Disease Activity at Week 26 Week 26 | ADA + 10 mg MTX | 56.6 percentage of participants |
| ADA + 2.5 mg MTX | 42.9 percentage of participants | |||
| ADA + 20 mg MTX | 60.2 percentage of participants | |||
| ADA + 5 mg MTX | 44.0 percentage of participants | |||
| NCT01231321 | Arthritis, Rheumatoid | Changes of Physical Examination Baseline and 24 weeks | Change From Abnormal to Normal | 0 participants |
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 1 participants | |||
| Change From Abnormal to Normal | 1 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Abnormal to Normal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 1 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 1 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 1 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| Change From Normal to Abnormal | 0 participants | |||
| NCT01231321 | Arthritis, Rheumatoid | Deviation From Normal Laboratory Ranges 24 weeks | Above Reference Range | 6 participants |
| Above Reference Range | 1 participants | |||
| Above Reference Range | 11 participants | |||
| Above Reference Range | 2 participants | |||
| Above Reference Range | 30 participants | |||
| Above Reference Range | 2 participants | |||
| Above Reference Range | 14 participants | |||
| Above Reference Range | 9 participants | |||
| Above Reference Range | 0 participants | |||
| Above Reference Range | 11 participants | |||
| Above Reference Range | 0 participants | |||
| Above Reference Range | 0 participants | |||
| Above Reference Range | 9 participants | |||
| Above Reference Range | 24 participants | |||
| Above Reference Range | 6 participants | |||
| Above Reference Range | 12 participants | |||
| Above Reference Range | 6 participants | |||
| Above Reference Range | 6 participants | |||
| Above Reference Range | 3 participants | |||
| Above Reference Range | 14 participants | |||
| Above Reference Range | 2 participants | |||
| Above Reference Range | 9 participants | |||
| Above Reference Range | 6 participants | |||
| Above Reference Range | 0 participants | |||
| Above Reference Range | 0 participants | |||
| Above Reference Range | 2 participants | |||
| Above Reference Range | 1 participants | |||
| Above Reference Range | 45 participants | |||
| Above Reference Range | 10 participants | |||
| Above Reference Range | 0 participants | |||
| Above Reference Range | 0 participants | |||
| Above Reference Range | 5 participants | |||
| Above Reference Range | 4 participants | |||
| Above Reference Range | 1 participants | |||
| Above Reference Range | 10 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 3 participants | |||
| Below Reference Range | 15 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 11 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 3 participants | |||
| Below Reference Range | 5 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 2 participants | |||
| Below Reference Range | 21 participants | |||
| Below Reference Range | 4 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 1 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 33 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 1 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 5 participants | |||
| Below Reference Range | 20 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 1 participants | |||
| Below Reference Range | 44 participants | |||
| Below Reference Range | 1 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 17 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 15 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 15 participants | |||
| NCT01231321 | Arthritis, Rheumatoid | Frequency of Adverse Events Up to 34 weeks (24 week study treatment plus 70-day follow-up period) | Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | 24 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | 3 participants | |||
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | 0 participants | |||
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | 38 participants | |||
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | 1 participants | |||
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | 1 participants | |||
| NCT01231321 | Arthritis, Rheumatoid | Vital Sign Values 24 weeks | Above Reference Range | 0 participants |
| Above Reference Range | 0 participants | |||
| Above Reference Range | 0 participants | |||
| Above Reference Range | 2 participants | |||
| Below Reference Range | 1 participants | |||
| Below Reference Range | 1 participants | |||
| Below Reference Range | 0 participants | |||
| Below Reference Range | 0 participants | |||
| NCT01235689 CALM | Crohn Disease | Percentage of Participants With Mucosal Healing and No Deep Ulcerations 48 weeks after Randomization | Clinically Driven Management | 30.3 percentage of participants |
| Tight Control Management | 45.9 percentage of participants | |||
| NCT01243671 | — | Number of Participants With Marked Improvement at Week 24 24 weeks | Adalimumab | 9 participants |
| NCT01251614 | — | Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of "Cleared" (0) or "Minimal" (1) at Week 16 Week 16 | Adalimumab 0.4 mg/kg | 41.0 percentage of participants |
| Adalimumab 0.8 mg/kg | 60.5 percentage of participants | |||
| Methotrexate | 40.5 percentage of participants | |||
| NCT01251614 | — | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 Baseline and Week 16 | Adalimumab 0.4 mg/kg | 43.6 percentage of participants |
| Adalimumab 0.8 mg/kg | 57.9 percentage of participants | |||
| Methotrexate | 32.4 percentage of participants | |||
| NCT01295814 | Cystitis, Interstitial | O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score Baseline/12 Weeks | Adalimumab | 19.9 units on a scale (±7.5 Standard Deviation) |
| Adalimumab | 27.8 units on a scale (±3.9 Standard Deviation) | |||
| Inactive Drug | 19.6 units on a scale (±10.7 Standard Deviation) | |||
| Inactive Drug | 27.7 units on a scale (±4.9 Standard Deviation) | |||
| NCT01468207 PIONEER I | Psoriasis | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 Baseline (Week 0) up to Week 12 | Adalimumab Every Week (EW) | 41.8 percentage of participants |
| Adalimumab Every Week (EW) - Baseline Hurley Stage II | 44.6 percentage of participants | |||
| Adalimumab Every Week (ew) - Baseline Hurley Stage III | 38.6 percentage of participants | |||
| Placebo | 26.0 percentage of participants | |||
| Placebo - Baseline Hurley Stage II | 29.8 percentage of participants | |||
| Placebo - Baseline Hurley Stage III | 21.4 percentage of participants | |||
| NCT01468233 PIONEER II | Psoriasis | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 Baseline (Week 0) up to Week 12 | Adalimumab Every Week (EW) | 58.9 percentage of participants |
| Adalimumab Every Week (EW) - Baseline Hurley Stage II | 62.4 percentage of participants | |||
| Adalimumab Every Week (EW) - Baseline Hurley Stage III | 55.1 percentage of participants | |||
| Placebo | 27.6 percentage of participants | |||
| Placebo - Baseline Hurley Stage II | 36.8 percentage of participants | |||
| Placebo - Baseline Hurley Stage III | 17.1 percentage of participants | |||
| NCT01550965 InspirAda | Colitis, Ulcerative | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Week 0 (baseline) and Week 26 | Participants Receiving Adalimumab | 17.4 units on a scale (±14.48 Standard Deviation) |
| NCT01550965 InspirAda | Colitis, Ulcerative | Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) | Participants Receiving Adalimumab | -1383.8 Pound Sterling (GBP) (±2213.06 Standard Deviation) |
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Baseline (in prior phase 3 study) to Entry of M12-555 and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | EW/EOW/EW | -34.9 units on a scale (±47.42 Standard Deviation) |
| EW/EOW/EW | -23.1 units on a scale (±56.94 Standard Deviation) | |||
| EW/EOW/EW | -36.6 units on a scale (±51.33 Standard Deviation) | |||
| EW/EOW/EW | -35.6 units on a scale (±53.64 Standard Deviation) | |||
| EW/EOW/EW | -34.0 units on a scale (±49.42 Standard Deviation) | |||
| EW/EOW/EW | -34.0 units on a scale (±54.41 Standard Deviation) | |||
| EW/EOW/EW | -35.6 units on a scale (±53.72 Standard Deviation) | |||
| EW/EOW/EW | -34.8 units on a scale (±55.71 Standard Deviation) | |||
| EW/EOW/EW | -35.1 units on a scale (±53.94 Standard Deviation) | |||
| EW/EOW/EW | -35.1 units on a scale (±53.01 Standard Deviation) | |||
| EW/EOW/EW | -34.7 units on a scale (±53.95 Standard Deviation) | |||
| EW/EOW/EW | -37.1 units on a scale (±46.07 Standard Deviation) | |||
| EW/EOW/EW | -35.6 units on a scale (±53.64 Standard Deviation) | |||
| EW/EOW/EW | -37.5 units on a scale (±47.94 Standard Deviation) | |||
| EW/EOW/EW | -37.1 units on a scale (±47.39 Standard Deviation) | |||
| EW/EOW/EW | -31.8 units on a scale (±60.85 Standard Deviation) | |||
| EW/EOW/EW | -34.8 units on a scale (±50.17 Standard Deviation) | |||
| EW/EOW/EW | -35.9 units on a scale (±47.92 Standard Deviation) | |||
| EW/EOW/EW | -30.2 units on a scale (±48.99 Standard Deviation) | |||
| EW/EOW/EW | -35.4 units on a scale (±55.22 Standard Deviation) | |||
| EW/PBO/EW | -16.7 units on a scale (±66.87 Standard Deviation) | |||
| EW/PBO/EW | -15.4 units on a scale (±67.39 Standard Deviation) | |||
| EW/PBO/EW | -15.4 units on a scale (±67.39 Standard Deviation) | |||
| EW/PBO/EW | -15.5 units on a scale (±67.40 Standard Deviation) | |||
| EW/PBO/EW | -15.7 units on a scale (±67.09 Standard Deviation) | |||
| EW/PBO/EW | -16.6 units on a scale (±67.30 Standard Deviation) | |||
| EW/PBO/EW | -18.3 units on a scale (±65.14 Standard Deviation) | |||
| EW/PBO/EW | -20.0 units on a scale (±66.02 Standard Deviation) | |||
| EW/PBO/EW | -20.1 units on a scale (±64.52 Standard Deviation) | |||
| EW/PBO/EW | -22.6 units on a scale (±65.06 Standard Deviation) | |||
| EW/PBO/EW | -24.8 units on a scale (±63.21 Standard Deviation) | |||
| EW/PBO/EW | -24.7 units on a scale (±63.81 Standard Deviation) | |||
| EW/PBO/EW | -24.1 units on a scale (±61.52 Standard Deviation) | |||
| EW/PBO/EW | -26.2 units on a scale (±60.59 Standard Deviation) | |||
| EW/PBO/EW | -25.5 units on a scale (±57.92 Standard Deviation) | |||
| EW/PBO/EW | -21.2 units on a scale (±63.26 Standard Deviation) | |||
| EW/PBO/EW | -18.8 units on a scale (±56.52 Standard Deviation) | |||
| EW/PBO/EW | -10.5 units on a scale (±56.74 Standard Deviation) | |||
| EW/PBO/EW | -16.2 units on a scale (±66.82 Standard Deviation) | |||
| EW/PBO/EW | -18.3 units on a scale (±66.88 Standard Deviation) | |||
| PBO/PBO/EW | -26.2 units on a scale (±54.58 Standard Deviation) | |||
| PBO/PBO/EW | -33.5 units on a scale (±50.20 Standard Deviation) | |||
| PBO/PBO/EW | 0.2 units on a scale (±51.35 Standard Deviation) | |||
| PBO/PBO/EW | -24.8 units on a scale (±51.55 Standard Deviation) | |||
| PBO/PBO/EW | -16.2 units on a scale (±56.16 Standard Deviation) | |||
| PBO/PBO/EW | -30.2 units on a scale (±64.84 Standard Deviation) | |||
| PBO/PBO/EW | -28.4 units on a scale (±71.52 Standard Deviation) | |||
| PBO/PBO/EW | -32.3 units on a scale (±48.60 Standard Deviation) | |||
| PBO/PBO/EW | -28.7 units on a scale (±69.81 Standard Deviation) | |||
| PBO/PBO/EW | -28.7 units on a scale (±69.81 Standard Deviation) | |||
| PBO/PBO/EW | -28.3 units on a scale (±70.37 Standard Deviation) | |||
| PBO/PBO/EW | -28.8 units on a scale (±69.79 Standard Deviation) | |||
| PBO/PBO/EW | -31.7 units on a scale (±66.33 Standard Deviation) | |||
| PBO/PBO/EW | -33.6 units on a scale (±57.58 Standard Deviation) | |||
| PBO/PBO/EW | -31.8 units on a scale (±65.26 Standard Deviation) | |||
| PBO/PBO/EW | -29.5 units on a scale (±65.79 Standard Deviation) | |||
| PBO/PBO/EW | -29.0 units on a scale (±68.85 Standard Deviation) | |||
| PBO/PBO/EW | -28.6 units on a scale (±70.03 Standard Deviation) | |||
| PBO/PBO/EW | -28.0 units on a scale (±69.11 Standard Deviation) | |||
| PBO/PBO/EW | -28.7 units on a scale (±69.81 Standard Deviation) | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population Baseline (in prior phase 3 study) to Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | EW/EW/EW | -41.8 units on a scale (±129.89 Standard Deviation) |
| EW/EW/EW | -41.6 units on a scale (±93.11 Standard Deviation) | |||
| EW/EW/EW | -41.4 units on a scale (±130.94 Standard Deviation) | |||
| EW/EW/EW | -42.2 units on a scale (±115.22 Standard Deviation) | |||
| EW/EW/EW | -26.6 units on a scale (±54.63 Standard Deviation) | |||
| EW/EW/EW | -41.9 units on a scale (±119.98 Standard Deviation) | |||
| EW/EW/EW | -43.2 units on a scale (±122.30 Standard Deviation) | |||
| EW/EW/EW | -22.8 units on a scale (±35.45 Standard Deviation) | |||
| EW/EW/EW | -42.8 units on a scale (±123.18 Standard Deviation) | |||
| EW/EW/EW | -43.2 units on a scale (±126.21 Standard Deviation) | |||
| EW/EW/EW | -18.0 units on a scale (±25.27 Standard Deviation) | |||
| EW/EW/EW | -43.2 units on a scale (±124.92 Standard Deviation) | |||
| EW/EW/EW | -43.4 units on a scale (±127.65 Standard Deviation) | |||
| EW/EW/EW | -21.0 units on a scale (±31.81 Standard Deviation) | |||
| EW/EW/EW | -42.5 units on a scale (±128.45 Standard Deviation) | |||
| EW/EW/EW | -42.4 units on a scale (±129.37 Standard Deviation) | |||
| EW/EW/EW | -32.1 units on a scale (±73.69 Standard Deviation) | |||
| EW/EW/EW | -36.6 units on a scale (±74.99 Standard Deviation) | |||
| EW/EW/EW | -23.9 units on a scale (±48.30 Standard Deviation) | |||
| EW/EW/EW | -40.7 units on a scale (±130.30 Standard Deviation) | |||
| EW/EW/EW | -41.5 units on a scale (±130.40 Standard Deviation) | |||
| EW/EW/EW | -41.9 units on a scale (±130.46 Standard Deviation) | |||
| EW/EW/EW | -41.4 units on a scale (±130.72 Standard Deviation) | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population Baseline (in prior phase 3 study) to Entry of Period B in prior phase 3 study and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | PBO/EW/EW | -45.8 units on a scale (±75.89 Standard Deviation) |
| PBO/EW/EW | -45.9 units on a scale (±75.30 Standard Deviation) | |||
| PBO/EW/EW | -44.4 units on a scale (±78.09 Standard Deviation) | |||
| PBO/EW/EW | -47.1 units on a scale (±61.95 Standard Deviation) | |||
| PBO/EW/EW | -45.8 units on a scale (±75.96 Standard Deviation) | |||
| PBO/EW/EW | -45.4 units on a scale (±76.53 Standard Deviation) | |||
| PBO/EW/EW | -49.5 units on a scale (±57.05 Standard Deviation) | |||
| PBO/EW/EW | -45.9 units on a scale (±75.96 Standard Deviation) | |||
| PBO/EW/EW | -46.0 units on a scale (±76.17 Standard Deviation) | |||
| PBO/EW/EW | -43.0 units on a scale (±53.08 Standard Deviation) | |||
| PBO/EW/EW | -43.2 units on a scale (±48.07 Standard Deviation) | |||
| PBO/EW/EW | -46.1 units on a scale (±75.84 Standard Deviation) | |||
| PBO/EW/EW | -18.0 units on a scale (±38.32 Standard Deviation) | |||
| PBO/EW/EW | -44.5 units on a scale (±67.13 Standard Deviation) | |||
| PBO/EW/EW | -46.8 units on a scale (±64.57 Standard Deviation) | |||
| PBO/EW/EW | -45.5 units on a scale (±70.63 Standard Deviation) | |||
| PBO/EW/EW | -45.0 units on a scale (±74.15 Standard Deviation) | |||
| PBO/EW/EW | -46.2 units on a scale (±60.94 Standard Deviation) | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | EW/EOW/EW | 41.3 percentage of participants |
| EW/EOW/EW | 49.2 percentage of participants | |||
| EW/EOW/EW | 42.9 percentage of participants | |||
| EW/EOW/EW | 47.6 percentage of participants | |||
| EW/EOW/EW | 41.3 percentage of participants | |||
| EW/EOW/EW | 45.2 percentage of participants | |||
| EW/EOW/EW | 47.5 percentage of participants | |||
| EW/EOW/EW | 40.0 percentage of participants | |||
| EW/EOW/EW | 41.3 percentage of participants | |||
| EW/EOW/EW | 42.9 percentage of participants | |||
| EW/EOW/EW | 41.3 percentage of participants | |||
| EW/EOW/EW | 39.7 percentage of participants | |||
| EW/EOW/EW | 47.6 percentage of participants | |||
| EW/EOW/EW | 41.3 percentage of participants | |||
| EW/EOW/EW | 47.6 percentage of participants | |||
| EW/EOW/EW | 41.3 percentage of participants | |||
| EW/EOW/EW | 50.8 percentage of participants | |||
| EW/EOW/EW | 50.8 percentage of participants | |||
| EW/EOW/EW | 50.8 percentage of participants | |||
| EW/EOW/EW | 47.6 percentage of participants | |||
| EW/PBO/EW | 49.2 percentage of participants | |||
| EW/PBO/EW | 47.6 percentage of participants | |||
| EW/PBO/EW | 50.8 percentage of participants | |||
| EW/PBO/EW | 46.0 percentage of participants | |||
| EW/PBO/EW | 42.9 percentage of participants | |||
| EW/PBO/EW | 50.8 percentage of participants | |||
| EW/PBO/EW | 49.2 percentage of participants | |||
| EW/PBO/EW | 46.0 percentage of participants | |||
| EW/PBO/EW | 49.2 percentage of participants | |||
| EW/PBO/EW | 47.6 percentage of participants | |||
| EW/PBO/EW | 21.9 percentage of participants | |||
| EW/PBO/EW | 47.6 percentage of participants | |||
| EW/PBO/EW | 43.1 percentage of participants | |||
| EW/PBO/EW | 50.8 percentage of participants | |||
| EW/PBO/EW | 47.6 percentage of participants | |||
| EW/PBO/EW | 42.9 percentage of participants | |||
| EW/PBO/EW | 54.0 percentage of participants | |||
| EW/PBO/EW | 55.6 percentage of participants | |||
| EW/PBO/EW | 50.8 percentage of participants | |||
| EW/PBO/EW | 47.6 percentage of participants | |||
| PBO/PBO/EW | 55.4 percentage of participants | |||
| PBO/PBO/EW | 54.2 percentage of participants | |||
| PBO/PBO/EW | 48.2 percentage of participants | |||
| PBO/PBO/EW | 48.2 percentage of participants | |||
| PBO/PBO/EW | 48.2 percentage of participants | |||
| PBO/PBO/EW | 50.6 percentage of participants | |||
| PBO/PBO/EW | 50.6 percentage of participants | |||
| PBO/PBO/EW | 48.2 percentage of participants | |||
| PBO/PBO/EW | 45.8 percentage of participants | |||
| PBO/PBO/EW | 50.6 percentage of participants | |||
| PBO/PBO/EW | 56.6 percentage of participants | |||
| PBO/PBO/EW | 47.0 percentage of participants | |||
| PBO/PBO/EW | 49.4 percentage of participants | |||
| PBO/PBO/EW | 55.4 percentage of participants | |||
| PBO/PBO/EW | 48.2 percentage of participants | |||
| PBO/PBO/EW | 48.2 percentage of participants | |||
| PBO/PBO/EW | 22.6 percentage of participants | |||
| PBO/PBO/EW | 44.6 percentage of participants | |||
| PBO/PBO/EW | 51.8 percentage of participants | |||
| PBO/PBO/EW | 51.8 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | EW/EOW/EW | 43.4 percentage of participants |
| EW/EOW/EW | 47.2 percentage of participants | |||
| EW/EOW/EW | 39.6 percentage of participants | |||
| EW/EOW/EW | 49.1 percentage of participants | |||
| EW/EOW/EW | 47.2 percentage of participants | |||
| EW/EOW/EW | 49.1 percentage of participants | |||
| EW/EOW/EW | 47.2 percentage of participants | |||
| EW/EOW/EW | 43.4 percentage of participants | |||
| EW/EOW/EW | 43.4 percentage of participants | |||
| EW/EOW/EW | 43.4 percentage of participants | |||
| EW/EOW/EW | 46.2 percentage of participants | |||
| EW/EOW/EW | 43.4 percentage of participants | |||
| EW/EOW/EW | 39.6 percentage of participants | |||
| EW/EOW/EW | 45.3 percentage of participants | |||
| EW/EOW/EW | 49.0 percentage of participants | |||
| EW/EOW/EW | 39.6 percentage of participants | |||
| EW/EOW/EW | 43.6 percentage of participants | |||
| EW/EOW/EW | 45.3 percentage of participants | |||
| EW/EOW/EW | 43.4 percentage of participants | |||
| EW/EOW/EW | 43.4 percentage of participants | |||
| EW/PBO/EW | 46.8 percentage of participants | |||
| EW/PBO/EW | 48.1 percentage of participants | |||
| EW/PBO/EW | 48.1 percentage of participants | |||
| EW/PBO/EW | 37.7 percentage of participants | |||
| EW/PBO/EW | 55.8 percentage of participants | |||
| EW/PBO/EW | 59.6 percentage of participants | |||
| EW/PBO/EW | 59.6 percentage of participants | |||
| EW/PBO/EW | 53.8 percentage of participants | |||
| EW/PBO/EW | 48.1 percentage of participants | |||
| EW/PBO/EW | 51.9 percentage of participants | |||
| EW/PBO/EW | 53.8 percentage of participants | |||
| EW/PBO/EW | 59.6 percentage of participants | |||
| EW/PBO/EW | 48.1 percentage of participants | |||
| EW/PBO/EW | 57.7 percentage of participants | |||
| EW/PBO/EW | 44.2 percentage of participants | |||
| EW/PBO/EW | 48.1 percentage of participants | |||
| EW/PBO/EW | 50.0 percentage of participants | |||
| EW/PBO/EW | 50.0 percentage of participants | |||
| EW/PBO/EW | 46.2 percentage of participants | |||
| EW/PBO/EW | 48.1 percentage of participants | |||
| PBO/PBO/EW | 58.8 percentage of participants | |||
| PBO/PBO/EW | 58.8 percentage of participants | |||
| PBO/PBO/EW | 54.4 percentage of participants | |||
| PBO/PBO/EW | 55.9 percentage of participants | |||
| PBO/PBO/EW | 61.8 percentage of participants | |||
| PBO/PBO/EW | 54.4 percentage of participants | |||
| PBO/PBO/EW | 63.2 percentage of participants | |||
| PBO/PBO/EW | 55.9 percentage of participants | |||
| PBO/PBO/EW | 61.8 percentage of participants | |||
| PBO/PBO/EW | 31.9 percentage of participants | |||
| PBO/PBO/EW | 52.9 percentage of participants | |||
| PBO/PBO/EW | 54.4 percentage of participants | |||
| PBO/PBO/EW | 54.4 percentage of participants | |||
| PBO/PBO/EW | 54.4 percentage of participants | |||
| PBO/PBO/EW | 55.9 percentage of participants | |||
| PBO/PBO/EW | 54.4 percentage of participants | |||
| PBO/PBO/EW | 57.4 percentage of participants | |||
| PBO/PBO/EW | 54.4 percentage of participants | |||
| PBO/PBO/EW | 58.8 percentage of participants | |||
| PBO/PBO/EW | 54.4 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | EW/EOW/EW | 51.1 percentage of participants |
| EW/EOW/EW | 31.1 percentage of participants | |||
| EW/EOW/EW | 35.6 percentage of participants | |||
| EW/EOW/EW | 43.2 percentage of participants | |||
| EW/EOW/EW | 45.5 percentage of participants | |||
| EW/EOW/EW | 50.0 percentage of participants | |||
| EW/EOW/EW | 43.2 percentage of participants | |||
| EW/EOW/EW | 54.5 percentage of participants | |||
| EW/EOW/EW | 50.0 percentage of participants | |||
| EW/EOW/EW | 48.9 percentage of participants | |||
| EW/EOW/EW | 50.0 percentage of participants | |||
| EW/EOW/EW | 53.4 percentage of participants | |||
| EW/EOW/EW | 51.1 percentage of participants | |||
| EW/EOW/EW | 51.1 percentage of participants | |||
| EW/EOW/EW | 46.6 percentage of participants | |||
| EW/EOW/EW | 51.1 percentage of participants | |||
| EW/EOW/EW | 48.9 percentage of participants | |||
| EW/EOW/EW | 47.7 percentage of participants | |||
| EW/EOW/EW | 51.1 percentage of participants | |||
| EW/EOW/EW | 51.1 percentage of participants | |||
| EW/PBO/EW | 43.5 percentage of participants | |||
| EW/PBO/EW | 35.9 percentage of participants | |||
| EW/PBO/EW | 35.9 percentage of participants | |||
| EW/PBO/EW | 35.9 percentage of participants | |||
| EW/PBO/EW | 39.1 percentage of participants | |||
| EW/PBO/EW | 41.3 percentage of participants | |||
| EW/PBO/EW | 37.0 percentage of participants | |||
| EW/PBO/EW | 37.0 percentage of participants | |||
| EW/PBO/EW | 40.2 percentage of participants | |||
| EW/PBO/EW | 40.2 percentage of participants | |||
| EW/PBO/EW | 44.6 percentage of participants | |||
| EW/PBO/EW | 43.5 percentage of participants | |||
| EW/PBO/EW | 42.4 percentage of participants | |||
| EW/PBO/EW | 45.7 percentage of participants | |||
| EW/PBO/EW | 46.7 percentage of participants | |||
| EW/PBO/EW | 41.3 percentage of participants | |||
| EW/PBO/EW | 44.6 percentage of participants | |||
| EW/PBO/EW | 42.4 percentage of participants | |||
| EW/PBO/EW | 34.8 percentage of participants | |||
| EW/PBO/EW | 22.8 percentage of participants | |||
| PBO/PBO/EW | 51.6 percentage of participants | |||
| PBO/PBO/EW | 57.4 percentage of participants | |||
| PBO/PBO/EW | 52.5 percentage of participants | |||
| PBO/PBO/EW | 21.1 percentage of participants | |||
| PBO/PBO/EW | 57.4 percentage of participants | |||
| PBO/PBO/EW | 50.8 percentage of participants | |||
| PBO/PBO/EW | 44.3 percentage of participants | |||
| PBO/PBO/EW | 50.0 percentage of participants | |||
| PBO/PBO/EW | 53.3 percentage of participants | |||
| PBO/PBO/EW | 53.3 percentage of participants | |||
| PBO/PBO/EW | 45.1 percentage of participants | |||
| PBO/PBO/EW | 52.5 percentage of participants | |||
| PBO/PBO/EW | 54.1 percentage of participants | |||
| PBO/PBO/EW | 52.5 percentage of participants | |||
| PBO/PBO/EW | 51.6 percentage of participants | |||
| PBO/PBO/EW | 51.6 percentage of participants | |||
| PBO/PBO/EW | 51.6 percentage of participants | |||
| PBO/PBO/EW | 51.6 percentage of participants | |||
| PBO/PBO/EW | 52.5 percentage of participants | |||
| PBO/PBO/EW | 51.6 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | EW/EW/EW | 46.0 percentage of participants |
| EW/EW/EW | 58.7 percentage of participants | |||
| EW/EW/EW | 52.4 percentage of participants | |||
| EW/EW/EW | 54.0 percentage of participants | |||
| EW/EW/EW | 52.4 percentage of participants | |||
| EW/EW/EW | 54.0 percentage of participants | |||
| EW/EW/EW | 52.4 percentage of participants | |||
| EW/EW/EW | 49.2 percentage of participants | |||
| EW/EW/EW | 54.0 percentage of participants | |||
| EW/EW/EW | 50.8 percentage of participants | |||
| EW/EW/EW | 46.0 percentage of participants | |||
| EW/EW/EW | 54.0 percentage of participants | |||
| EW/EW/EW | 52.4 percentage of participants | |||
| EW/EW/EW | 47.6 percentage of participants | |||
| EW/EW/EW | 46.0 percentage of participants | |||
| EW/EW/EW | 52.4 percentage of participants | |||
| EW/EW/EW | 44.4 percentage of participants | |||
| EW/EW/EW | 52.4 percentage of participants | |||
| EW/EW/EW | 42.9 percentage of participants | |||
| EW/EW/EW | 50.8 percentage of participants | |||
| EW/EW/EW | 54.0 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | EW/EW/EW | 56.0 percentage of participants |
| EW/EW/EW | 52.0 percentage of participants | |||
| EW/EW/EW | 46.0 percentage of participants | |||
| EW/EW/EW | 48.0 percentage of participants | |||
| EW/EW/EW | 56.0 percentage of participants | |||
| EW/EW/EW | 50.0 percentage of participants | |||
| EW/EW/EW | 50.0 percentage of participants | |||
| EW/EW/EW | 56.0 percentage of participants | |||
| EW/EW/EW | 40.0 percentage of participants | |||
| EW/EW/EW | 54.0 percentage of participants | |||
| EW/EW/EW | 56.0 percentage of participants | |||
| EW/EW/EW | 46.0 percentage of participants | |||
| EW/EW/EW | 56.0 percentage of participants | |||
| EW/EW/EW | 58.0 percentage of participants | |||
| EW/EW/EW | 56.0 percentage of participants | |||
| EW/EW/EW | 56.0 percentage of participants | |||
| EW/EW/EW | 56.0 percentage of participants | |||
| EW/EW/EW | 58.0 percentage of participants | |||
| EW/EW/EW | 48.0 percentage of participants | |||
| EW/EW/EW | 56.0 percentage of participants | |||
| EW/EW/EW | 56.0 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | EW/EW/EW | 42.0 percentage of participants |
| EW/EW/EW | 22.7 percentage of participants | |||
| EW/EW/EW | 28.4 percentage of participants | |||
| EW/EW/EW | 38.6 percentage of participants | |||
| EW/EW/EW | 35.2 percentage of participants | |||
| EW/EW/EW | 37.5 percentage of participants | |||
| EW/EW/EW | 36.4 percentage of participants | |||
| EW/EW/EW | 48.9 percentage of participants | |||
| EW/EW/EW | 46.6 percentage of participants | |||
| EW/EW/EW | 43.2 percentage of participants | |||
| EW/EW/EW | 50.0 percentage of participants | |||
| EW/EW/EW | 45.5 percentage of participants | |||
| EW/EW/EW | 44.3 percentage of participants | |||
| EW/EW/EW | 46.6 percentage of participants | |||
| EW/EW/EW | 44.3 percentage of participants | |||
| EW/EW/EW | 44.3 percentage of participants | |||
| EW/EW/EW | 43.2 percentage of participants | |||
| EW/EW/EW | 45.5 percentage of participants | |||
| EW/EW/EW | 46.6 percentage of participants | |||
| EW/EW/EW | 46.6 percentage of participants | |||
| EW/EW/EW | 47.7 percentage of participants | |||
| EW/EW/EW | 47.7 percentage of participants | |||
| EW/EW/EW | 46.6 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | EW/EOW/EW | 55.6 percentage of participants |
| EW/EOW/EW | 56.7 percentage of participants | |||
| EW/EOW/EW | 55.6 percentage of participants | |||
| EW/EOW/EW | 45.6 percentage of participants | |||
| EW/EOW/EW | 52.2 percentage of participants | |||
| EW/EOW/EW | 54.4 percentage of participants | |||
| EW/EOW/EW | 55.6 percentage of participants | |||
| EW/EOW/EW | 52.2 percentage of participants | |||
| EW/EOW/EW | 53.3 percentage of participants | |||
| EW/EOW/EW | 57.8 percentage of participants | |||
| EW/EOW/EW | 54.4 percentage of participants | |||
| EW/EOW/EW | 52.2 percentage of participants | |||
| EW/EOW/EW | 41.1 percentage of participants | |||
| EW/EOW/EW | 56.7 percentage of participants | |||
| EW/EOW/EW | 61.1 percentage of participants | |||
| EW/EOW/EW | 54.4 percentage of participants | |||
| EW/EOW/EW | 39.8 percentage of participants | |||
| EW/EOW/EW | 47.8 percentage of participants | |||
| EW/EOW/EW | 56.7 percentage of participants | |||
| EW/EOW/EW | 54.4 percentage of participants | |||
| EW/EOW/EW | 48.9 percentage of participants | |||
| EW/EOW/EW | 54.4 percentage of participants | |||
| EW/EOW/EW | 54.4 percentage of participants | |||
| EW/EW/EW | 48.9 percentage of participants | |||
| EW/EW/EW | 38.6 percentage of participants | |||
| EW/EW/EW | 51.1 percentage of participants | |||
| EW/EW/EW | 52.3 percentage of participants | |||
| EW/EW/EW | 50.0 percentage of participants | |||
| EW/EW/EW | 34.1 percentage of participants | |||
| EW/EW/EW | 56.8 percentage of participants | |||
| EW/EW/EW | 50.0 percentage of participants | |||
| EW/EW/EW | 50.0 percentage of participants | |||
| EW/EW/EW | 51.1 percentage of participants | |||
| EW/EW/EW | 51.1 percentage of participants | |||
| EW/EW/EW | 52.3 percentage of participants | |||
| EW/EW/EW | 48.9 percentage of participants | |||
| EW/EW/EW | 51.1 percentage of participants | |||
| EW/EW/EW | 52.3 percentage of participants | |||
| EW/EW/EW | 56.8 percentage of participants | |||
| EW/EW/EW | 60.2 percentage of participants | |||
| EW/EW/EW | 56.8 percentage of participants | |||
| EW/EW/EW | 56.8 percentage of participants | |||
| EW/EW/EW | 59.1 percentage of participants | |||
| EW/EW/EW | 62.5 percentage of participants | |||
| EW/EW/EW | 58.0 percentage of participants | |||
| EW/EW/EW | 62.5 percentage of participants | |||
| EW/PBO/EW | 46.7 percentage of participants | |||
| EW/PBO/EW | 34.1 percentage of participants | |||
| EW/PBO/EW | 53.3 percentage of participants | |||
| EW/PBO/EW | 46.7 percentage of participants | |||
| EW/PBO/EW | 52.2 percentage of participants | |||
| EW/PBO/EW | 55.4 percentage of participants | |||
| EW/PBO/EW | 46.7 percentage of participants | |||
| EW/PBO/EW | 40.2 percentage of participants | |||
| EW/PBO/EW | 53.3 percentage of participants | |||
| EW/PBO/EW | 45.7 percentage of participants | |||
| EW/PBO/EW | 45.7 percentage of participants | |||
| EW/PBO/EW | 58.7 percentage of participants | |||
| EW/PBO/EW | 51.1 percentage of participants | |||
| EW/PBO/EW | 52.2 percentage of participants | |||
| EW/PBO/EW | 50.0 percentage of participants | |||
| EW/PBO/EW | 42.4 percentage of participants | |||
| EW/PBO/EW | 50.0 percentage of participants | |||
| EW/PBO/EW | 46.7 percentage of participants | |||
| EW/PBO/EW | 58.7 percentage of participants | |||
| EW/PBO/EW | 45.7 percentage of participants | |||
| EW/PBO/EW | 46.7 percentage of participants | |||
| EW/PBO/EW | 47.8 percentage of participants | |||
| EW/PBO/EW | 53.3 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | PBO/EW/EW | 26.1 percentage of participants |
| PBO/EW/EW | 54.4 percentage of participants | |||
| PBO/EW/EW | 53.5 percentage of participants | |||
| PBO/EW/EW | 53.5 percentage of participants | |||
| PBO/EW/EW | 54.4 percentage of participants | |||
| PBO/EW/EW | 55.3 percentage of participants | |||
| PBO/EW/EW | 52.6 percentage of participants | |||
| PBO/EW/EW | 51.8 percentage of participants | |||
| PBO/EW/EW | 56.1 percentage of participants | |||
| PBO/EW/EW | 53.5 percentage of participants | |||
| PBO/EW/EW | 52.6 percentage of participants | |||
| PBO/EW/EW | 53.5 percentage of participants | |||
| PBO/EW/EW | 50.0 percentage of participants | |||
| PBO/EW/EW | 50.0 percentage of participants | |||
| PBO/EW/EW | 57.0 percentage of participants | |||
| PBO/EW/EW | 60.5 percentage of participants | |||
| PBO/EW/EW | 57.0 percentage of participants | |||
| PBO/EW/EW | 57.9 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | PBO/EW/EW | 51.3 percentage of participants |
| PBO/EW/EW | 55.1 percentage of participants | |||
| PBO/EW/EW | 53.8 percentage of participants | |||
| PBO/EW/EW | 56.4 percentage of participants | |||
| PBO/EW/EW | 55.1 percentage of participants | |||
| PBO/EW/EW | 62.3 percentage of participants | |||
| PBO/EW/EW | 63.6 percentage of participants | |||
| PBO/EW/EW | 64.9 percentage of participants | |||
| PBO/EW/EW | 58.4 percentage of participants | |||
| PBO/EW/EW | 53.2 percentage of participants | |||
| PBO/EW/EW | 55.8 percentage of participants | |||
| PBO/EW/EW | 55.3 percentage of participants | |||
| PBO/EW/EW | 51.6 percentage of participants | |||
| PBO/EW/EW | 31.6 percentage of participants | |||
| PBO/EW/EW | 57.7 percentage of participants | |||
| PBO/EW/EW | 56.4 percentage of participants | |||
| PBO/EW/EW | 57.7 percentage of participants | |||
| PBO/EW/EW | 57.7 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | PBO/EW/EW | 59.0 percentage of participants |
| PBO/EW/EW | 62.3 percentage of participants | |||
| PBO/EW/EW | 61.7 percentage of participants | |||
| PBO/EW/EW | 60.0 percentage of participants | |||
| PBO/EW/EW | 53.3 percentage of participants | |||
| PBO/EW/EW | 61.7 percentage of participants | |||
| PBO/EW/EW | 61.0 percentage of participants | |||
| PBO/EW/EW | 59.2 percentage of participants | |||
| PBO/EW/EW | 62.3 percentage of participants | |||
| PBO/EW/EW | 60.7 percentage of participants | |||
| PBO/EW/EW | 62.3 percentage of participants | |||
| PBO/EW/EW | 62.3 percentage of participants | |||
| PBO/EW/EW | 55.7 percentage of participants | |||
| PBO/EW/EW | 60.7 percentage of participants | |||
| PBO/EW/EW | 30.6 percentage of participants | |||
| PBO/EW/EW | 58.3 percentage of participants | |||
| PBO/EW/EW | 60.0 percentage of participants | |||
| PBO/EW/EW | 62.3 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | PBO/EW/EW | 45.6 percentage of participants |
| PBO/EW/EW | 49.1 percentage of participants | |||
| PBO/EW/EW | 45.6 percentage of participants | |||
| PBO/EW/EW | 46.5 percentage of participants | |||
| PBO/EW/EW | 45.6 percentage of participants | |||
| PBO/EW/EW | 45.6 percentage of participants | |||
| PBO/EW/EW | 45.6 percentage of participants | |||
| PBO/EW/EW | 43.9 percentage of participants | |||
| PBO/EW/EW | 20.0 percentage of participants | |||
| PBO/EW/EW | 38.6 percentage of participants | |||
| PBO/EW/EW | 43.0 percentage of participants | |||
| PBO/EW/EW | 42.1 percentage of participants | |||
| PBO/EW/EW | 45.6 percentage of participants | |||
| PBO/EW/EW | 43.9 percentage of participants | |||
| PBO/EW/EW | 43.9 percentage of participants | |||
| PBO/EW/EW | 46.5 percentage of participants | |||
| PBO/EW/EW | 42.1 percentage of participants | |||
| PBO/EW/EW | 46.5 percentage of participants | |||
| NCT01635764 PIONEER (OLE) | Hidradenitis Suppurativa | Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | PBO/PBO/EW | 51.6 percentage of participants |
| PBO/PBO/EW | 19.5 percentage of participants | |||
| PBO/PBO/EW | 46.7 percentage of participants | |||
| PBO/PBO/EW | 48.4 percentage of participants | |||
| PBO/PBO/EW | 57.4 percentage of participants | |||
| PBO/PBO/EW | 55.7 percentage of participants | |||
| PBO/PBO/EW | 60.7 percentage of participants | |||
| PBO/PBO/EW | 54.9 percentage of participants | |||
| PBO/PBO/EW | 55.7 percentage of participants | |||
| PBO/PBO/EW | 54.9 percentage of participants | |||
| PBO/PBO/EW | 54.9 percentage of participants | |||
| PBO/PBO/EW | 57.4 percentage of participants | |||
| PBO/PBO/EW | 54.9 percentage of participants | |||
| PBO/PBO/EW | 52.5 percentage of participants | |||
| PBO/PBO/EW | 54.1 percentage of participants | |||
| PBO/PBO/EW | 51.6 percentage of participants | |||
| PBO/PBO/EW | 50.8 percentage of participants | |||
| PBO/PBO/EW | 51.6 percentage of participants | |||
| PBO/PBO/EW | 51.6 percentage of participants | |||
| PBO/PBO/EW | 51.6 percentage of participants | |||
| NCT01646073 | Psoriasis | Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12 Week 12 | Adalimumab Eow | 77.8 percentage of participants |
| Placebo | 11.5 percentage of participants | |||
| NCT01695239 SPIRIT-P1 | Arthritis, Psoriatic | Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20]) Week 24 | Adalimumab Q2W | 57.4 percentage of participants |
| Ixekizumab Q2W | 62.1 percentage of participants | |||
| Ixekizumab Q4W | 57.9 percentage of participants | |||
| Placebo | 30.2 percentage of participants | |||
| NCT01710358 RA-BEAM | Arthritis, Rheumatoid | Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) Week 12 | Adalimumab | 61.2 percentage of participants |
| Baricitinib | 69.6 percentage of participants | |||
| Placebo | 40.2 percentage of participants | |||
| NCT01808118 | Spondylitis, Ankylosing | Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68 From Week 28 through 68 | Double-blind Adalimumab (Period 2) | 107 Participants |
| Placebo (Period 2) | 72 Participants | |||
| NCT01877668 OPAL BROADEN | Arthritis, Psoriatic | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score From Baseline to Month 3 | Adalimumab, 40 mg, Every 2 Weeks | -0.3808 Units on a scale (±0.04767 Standard Error) |
| Adalimumab, 40 mg, Every 2 Weeks | -0.3028 Units on a scale (±0.04465 Standard Error) | |||
| Adalimumab, 40 mg, Every 2 Weeks | -0.4304 Units on a scale (±0.05143 Standard Error) | |||
| Adalimumab, 40 mg, Every 2 Weeks | -0.4478 Units on a scale (±0.05426 Standard Error) | |||
| Adalimumab, 40 mg, Every 2 Weeks | -0.4259 Units on a scale (±0.05227 Standard Error) | |||
| Adalimumab, 40 mg, Every 2 Weeks | -0.2129 Units on a scale (±0.04246 Standard Error) | |||
| Adalimumab, 40 mg, Every 2 Weeks | -0.3643 Units on a scale (±0.05069 Standard Error) | |||
| Adalimumab, 40 mg, Every 2 Weeks | -0.3736 Units on a scale (±0.04719 Standard Error) | |||
| Placebo | NA Units on a scale (±NA Standard Error) | |||
| Placebo | NA Units on a scale (±NA Standard Error) | |||
| Placebo | -0.0837 Units on a scale (±0.04549 Standard Error) | |||
| Placebo | -0.1802 Units on a scale (±0.05031 Standard Error) | |||
| Placebo | NA Units on a scale (±NA Standard Error) | |||
| Placebo | -0.1224 Units on a scale (±0.04755 Standard Error) | |||
| Placebo | -0.1682 Units on a scale (±0.04998 Standard Error) | |||
| Placebo | NA Units on a scale (±NA Standard Error) | |||
| Placebo/Tofacitinib, 10 mg, Twice Daily | NA Units on a scale (±NA Standard Error) | |||
| Placebo/Tofacitinib, 10 mg, Twice Daily | NA Units on a scale (±NA Standard Error) | |||
| Placebo/Tofacitinib, 10 mg, Twice Daily | -0.3302 Units on a scale (±0.07128 Standard Error) | |||
| Placebo/Tofacitinib, 10 mg, Twice Daily | -0.4569 Units on a scale (±0.07704 Standard Error) | |||
| Placebo/Tofacitinib, 10 mg, Twice Daily | -0.4839 Units on a scale (±0.07276 Standard Error) | |||
| Placebo/Tofacitinib, 10 mg, Twice Daily | -0.3841 Units on a scale (±0.07369 Standard Error) | |||
| Placebo/Tofacitinib, 10 mg, Twice Daily | NA Units on a scale (±NA Standard Error) | |||
| Placebo/Tofacitinib, 5 mg, Twice Daily | NA Units on a scale (±NA Standard Error) | |||
| Placebo/Tofacitinib, 5 mg, Twice Daily | -0.4104 Units on a scale (±0.07646 Standard Error) | |||
| Placebo/Tofacitinib, 5 mg, Twice Daily | -0.3142 Units on a scale (±0.07315 Standard Error) | |||
| Placebo/Tofacitinib, 5 mg, Twice Daily | -0.3843 Units on a scale (±0.07185 Standard Error) | |||
| Placebo/Tofacitinib, 5 mg, Twice Daily | NA Units on a scale (±NA Standard Error) | |||
| Placebo/Tofacitinib, 5 mg, Twice Daily | -0.2850 Units on a scale (±0.07075 Standard Error) | |||
| Placebo/Tofacitinib, 5 mg, Twice Daily | NA Units on a scale (±NA Standard Error) | |||
| Tofacitinib, 10 mg, Twice Daily | -0.4009 Units on a scale (±0.04678 Standard Error) | |||
| Tofacitinib, 10 mg, Twice Daily | -0.4611 Units on a scale (±0.05179 Standard Error) | |||
| Tofacitinib, 10 mg, Twice Daily | -0.2676 Units on a scale (±0.04426 Standard Error) | |||
| Tofacitinib, 10 mg, Twice Daily | -0.3998 Units on a scale (±0.04716 Standard Error) | |||
| Tofacitinib, 10 mg, Twice Daily | -0.2089 Units on a scale (±0.04208 Standard Error) | |||
| Tofacitinib, 10 mg, Twice Daily | -0.4847 Units on a scale (±0.05096 Standard Error) | |||
| Tofacitinib, 10 mg, Twice Daily | -0.5104 Units on a scale (±0.05365 Standard Error) | |||
| Tofacitinib, 10 mg, Twice Daily | -0.4407 Units on a scale (±0.05039 Standard Error) | |||
| Tofacitinib, 5 mg, Twice Daily | -0.5391 Units on a scale (±0.05324 Standard Error) | |||
| Tofacitinib, 5 mg, Twice Daily | -0.3499 Units on a scale (±0.04665 Standard Error) | |||
| Tofacitinib, 5 mg, Twice Daily | -0.4471 Units on a scale (±0.05136 Standard Error) | |||
| Tofacitinib, 5 mg, Twice Daily | -0.4231 Units on a scale (±0.04982 Standard Error) | |||
| Tofacitinib, 5 mg, Twice Daily | -0.2713 Units on a scale (±0.04626 Standard Error) | |||
| Tofacitinib, 5 mg, Twice Daily | -0.2048 Units on a scale (±0.04363 Standard Error) | |||
| Tofacitinib, 5 mg, Twice Daily | -0.1842 Units on a scale (±0.04131 Standard Error) | |||
| Tofacitinib, 5 mg, Twice Daily | -0.5119 Units on a scale (±0.05038 Standard Error) | |||
| NCT01877668 OPAL BROADEN | Arthritis, Psoriatic | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 At end of Month 3 | Adalimumab, 40 mg, Every 2 Weeks | 51.89 Percentage or participants |
| Placebo | 33.33 Percentage or participants | |||
| Tofacitinib, 10 mg, Twice Daily | 60.58 Percentage or participants | |||
| Tofacitinib, 5 mg, Twice Daily | 50.47 Percentage or participants | |||
| NCT01958827 | Crohn Disease | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8 Week 8 | Adalimumab 80 mg | 75 percentage of participants |
| NCT01970475 | Arthritis, Rheumatoid | Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24 Baseline and Week 24 | ABP 501 | 74.6 percentage of participants |
| Adalimumab | 72.4 percentage of participants | |||
| NCT01970488 | Psoriasis | Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 Baseline and Week 16 | Part 1: ABP 501 | 80.91 percent change (±24.237 Standard Deviation) |
| Part 1: Adalimumab | 83.06 percent change (±25.195 Standard Deviation) | |||
| NCT02016105 ADACCESS | — | PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab At Week 16 only | GP2017 Adalimumab | 66.8 percent of participants |
| Humira ® Adalimumab | 65.0 percent of participants | |||
| NCT02016482 | — | For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "Minimal" at Week 26 Week 26 | Adalimumab EOW | 48.9 percentage of participants |
| Placebo | 6.9 percentage of participants | |||
| NCT02016482 | — | Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26 Week 26 | Adalimumab EOW | 46.6 percentage of participants |
| Placebo | 3.4 percentage of participants | |||
| NCT02019472 SIRROUND-H | Arthritis, Rheumatoid | Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24 Baseline and Week 24 | Adalimumab 40 mg | -2.19 units on a scale (±1.437 Standard Deviation) |
| Adalimumab 40 mg | 6.89 units on a scale (±0.851 Standard Deviation) | |||
| Sirukumab 100 mg | 6.91 units on a scale (±0.863 Standard Deviation) | |||
| Sirukumab 100 mg | -2.96 units on a scale (±1.58 Standard Deviation) | |||
| Sirukumab 50 mg | -2.58 units on a scale (±1.524 Standard Deviation) | |||
| Sirukumab 50 mg | 6.90 units on a scale (±0.881 Standard Deviation) | |||
| NCT02019472 SIRROUND-H | Arthritis, Rheumatoid | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24 Week 24 | Adalimumab 40 mg | 31.7 Percentage of participants |
| Sirukumab 100 mg | 35.3 Percentage of participants | |||
| Sirukumab 50 mg | 26.9 Percentage of participants | |||
| NCT02065557 | Colitis, Ulcerative | Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period Week 8 | Integrated Study (Main + Japan Sub-Study): I-HD | 58.8 percentage of participants |
| Integrated Study (Main + Japan Sub-Study): I-HD-OL | 66.7 percentage of participants | |||
| Integrated Study (Main + Japan Sub-Study): I-SD | 40.6 percentage of participants | |||
| Integrated Study (Main + Japan Sub-Study): I-SD + I-HD | 51.8 percentage of participants | |||
| Main Study: I-HD | 59.6 percentage of participants | |||
| Main Study: I-HD-OL | 68.8 percentage of participants | |||
| Main Study: I-SD | 43.3 percentage of participants | |||
| Main Study: I-SD + I-HD | 53.2 percentage of participants | |||
| NCT02065557 | Colitis, Ulcerative | Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period Week 52 | Integrated Study (Main + Japan Sub-Study): M-HD | 42.9 percentage of participants |
| Integrated Study (Main + Japan Sub-Study): M-PL | 33.3 percentage of participants | |||
| Integrated Study (Main + Japan Sub-Study): M-SD | 27.3 percentage of participants | |||
| Integrated Study (Main + Japan Sub-Study): M-SD + M-HD | 35.3 percentage of participants | |||
| Main Study: M-HD | 45.2 percentage of participants | |||
| Main Study: M-PL | 33.3 percentage of participants | |||
| Main Study: M-SD | 29.0 percentage of participants | |||
| Main Study: M-SD + M-HD | 37.1 percentage of participants | |||
| NCT02065570 | Crohn Disease | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks). | Induction: Higher Induction Dose | 17 Participants |
| Induction: Higher Induction Dose | 13 Participants | |||
| Induction: Higher Induction Dose | 0 Participants | |||
| Induction: Higher Induction Dose | 14 Participants | |||
| Induction: Higher Induction Dose | 0 Participants | |||
| Induction: Higher Induction Dose | 185 Participants | |||
| Induction: Higher Induction Dose | 75 Participants | |||
| Induction: Standard Induction Dose | 8 Participants | |||
| Induction: Standard Induction Dose | 10 Participants | |||
| Induction: Standard Induction Dose | 0 Participants | |||
| Induction: Standard Induction Dose | 13 Participants | |||
| Induction: Standard Induction Dose | 0 Participants | |||
| Induction: Standard Induction Dose | 133 Participants | |||
| Induction: Standard Induction Dose | 54 Participants | |||
| Maintenance: Clinically Adjusted (CA) Regimen | 5 Participants | |||
| Maintenance: Clinically Adjusted (CA) Regimen | 7 Participants | |||
| Maintenance: Clinically Adjusted (CA) Regimen | 0 Participants | |||
| Maintenance: Clinically Adjusted (CA) Regimen | 0 Participants | |||
| Maintenance: Clinically Adjusted (CA) Regimen | 29 Participants | |||
| Maintenance: Clinically Adjusted (CA) Regimen | 77 Participants | |||
| Maintenance: Clinically Adjusted (CA) Regimen | 8 Participants | |||
| Maintenance: Therapeutic Drug Monitoring (TDM) Regimen | 76 Participants | |||
| Maintenance: Therapeutic Drug Monitoring (TDM) Regimen | 0 Participants | |||
| Maintenance: Therapeutic Drug Monitoring (TDM) Regimen | 0 Participants | |||
| Maintenance: Therapeutic Drug Monitoring (TDM) Regimen | 9 Participants | |||
| Maintenance: Therapeutic Drug Monitoring (TDM) Regimen | 7 Participants | |||
| Maintenance: Therapeutic Drug Monitoring (TDM) Regimen | 6 Participants | |||
| Maintenance: Therapeutic Drug Monitoring (TDM) Regimen | 33 Participants | |||
| NCT02065570 | Crohn Disease | Percentage of Participants Who Achieved Clinical Remission at Week 4 Week 4 | Induction: Higher Induction Dose | 43.5 percentage of participants |
| Induction: Standard Induction Dose | 43.7 percentage of participants | |||
| NCT02065570 | Crohn Disease | Percentage of Participants With Endoscopic Response at Week 12 Week 12 | Induction: Higher Induction Dose | 42.9 percentage of participants |
| Induction: Standard Induction Dose | 39.3 percentage of participants | |||
| NCT02065622 | Colitis, Ulcerative | Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8 Week 8 | Induction (Main Study + Japan Sub-study): I-HD | 13.8 percentage of participants |
| Induction (Main Study + Japan Sub-study): I-SD | 11.6 percentage of participants | |||
| Induction (Main Study): I-HD | 13.3 percentage of participants | |||
| Induction (Main Study): I-SD | 10.9 percentage of participants | |||
| NCT02065622 | Colitis, Ulcerative | Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52 Week 52 | Maintenance (Main Study + Japan Sub-study): M-HD | 41.1 percentage of participants |
| Maintenance (Main Study + Japan Sub-study): M-SD | 30.1 percentage of participants | |||
| Maintenance (Main Study): M-HD | 39.5 percentage of participants | |||
| Maintenance (Main Study): M-SD | 29.0 percentage of participants | |||
| NCT02163759 HIBISCUS I | Colitis, Ulcerative | Percentage of Participants in Remission at Week 10 With Etrolizumab as Compared With Placebo, as Determined by the Mayo Clinic Score (MCS), GA28948 Population Week 10 | Etrolizumab | 19.4 Percentage of participants |
| Placebo | 6.9 Percentage of participants | |||
| NCT02167139 | Arthritis, Rheumatoid | American College of Rheumatology 20% Response Criteria (ACR20) Week 24 | Humira (Adalimumab) | 72.2 percentage of participants |
| SB5 (Proposed Biosimilar to Adalimumab) | 72.4 percentage of participants | |||
| NCT02171429 HIBISCUS II | Colitis, Ulcerative | Percentage of Participants in Remission at Week 10 With Etrolizumab Compared With Placebo, as Determined by the Mayo Clinic Score (MCS), GA28949 Population Week 10 | Etrolizumab | 18.2 Percentage of participants |
| Placebo | 11.1 Percentage of participants | |||
| NCT02185014 | Crohn Disease | Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0 Week 40 | Adalimumab | 31.6 percentage of participants |
| NCT02196701 CLEAR | Psoriasis | Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment Week 16 | Adalimumab + Methotrexate | 50.0 percentage of participants |
| Primary Sub-optimal Responders - ADA + MTX | 33.3 percentage of participants | |||
| Secondary Sub-optimal Responders - ADA + MTX | 52.5 percentage of participants | |||
| NCT02196701 CLEAR | Psoriasis | Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment Week 16 | Adalimumab + Methotrexate | 47.8 percentage of participants |
| Primary Sub-optimal Responders - ADA + MTX | 16.7 percentage of participants | |||
| Secondary Sub-optimal Responders - ADA + MTX | 52.5 percentage of participants | |||
| NCT02207231 VOYAGE 1 | Psoriasis | Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 Week 16 | Guselkumab | 85.1 percentage of participants |
| Placebo | 6.9 percentage of participants | |||
| NCT02207231 VOYAGE 1 | Psoriasis | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 Week 16 | Guselkumab | 73.3 percentage of participants |
| Placebo | 2.9 percentage of participants | |||
| NCT02207244 VOYAGE 2 | Psoriasis | Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 Week 16 | Guselkumab 100 mg | 84.1 percentage of participants |
| Placebo | 8.5 percentage of participants | |||
| NCT02207244 VOYAGE 2 | Psoriasis | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 Week 16 | Guselkumab 100 mg | 70.0 percentage of participants |
| Placebo | 2.4 percentage of participants | |||
| NCT02332590 | Arthritis, Rheumatoid | DB Period: Change From Baseline in Disease Activity Score for 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 24 Baseline, Week 24 | Adalimumab 40 mg/Sarilumab 200 mg | -2.20 units on a scale (±0.106 Standard Error) |
| Sarilumab 200 mg/Sarilumab 200 mg | -3.28 units on a scale (±0.105 Standard Error) | |||
| NCT02480153 | Arthritis, Rheumatoid | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1 Week 12 | Period 1: Adalimumab-EU | 71.33 percentage of participants |
| Period 1: PF-06410293 | 68.35 percentage of participants | |||
| NCT02489227 PsOsim | — | Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12 12 weeks | CHS-1420 | 211 Participants |
| Humira (Adalimumab) | 203 Participants | |||
| NCT02497469 | Colitis, Ulcerative | Percentage of Participants Who Achieved Clinical Remission Week 52 | Adalimumab SC, 160/80/40 mg | 22.5 percentage of participants |
| Vedolizumab IV 300 mg | 31.3 percentage of participants | |||
| NCT02499783 | Crohn Disease | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4 Week 4 | Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | 37.3 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | 6.8 percentage of participants | |||
| NCT02533375 | Psoriasis | Proportion of Participants Achieving Clinical Response at Week 16 Baseline and Week 16 | Participants Receiving Adalimumab | 7 Participants |
| NCT02629159 SELECT-COMPARE | Arthritis, Rheumatoid | Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12 Week 12 | Adalimumab | 18.0 percentage of participants |
| Placebo | 6.1 percentage of participants | |||
| Upadacitinib | 28.7 percentage of participants | |||
| NCT02629159 SELECT-COMPARE | Arthritis, Rheumatoid | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 Baseline and Week 12 | Adalimumab | 63.0 percentage of participants |
| Placebo | 36.4 percentage of participants | |||
| Upadacitinib | 70.5 percentage of participants | |||
| NCT02632175 | Colitis, Ulcerative | Number of Participants With Adverse Events (AEs) From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks). | Adalimumab | 15 Participants |
| Adalimumab | 55 Participants | |||
| NCT02632175 | Colitis, Ulcerative | Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 | Adalimumab | 32 Participants |
| Adalimumab | 25 Participants | |||
| Adalimumab | 27 Participants | |||
| Adalimumab | 28 Participants | |||
| Adalimumab | 29 Participants | |||
| Adalimumab | 30 Participants | |||
| Adalimumab | 31 Participants | |||
| Adalimumab | 33 Participants | |||
| Adalimumab | 37 Participants | |||
| Adalimumab | 36 Participants | |||
| Adalimumab | 40 Participants | |||
| Adalimumab | 42 Participants | |||
| Adalimumab | 42 Participants | |||
| Adalimumab | 40 Participants | |||
| Adalimumab | 45 Participants | |||
| Adalimumab | 43 Participants | |||
| Adalimumab | 51 Participants | |||
| Adalimumab | 47 Participants | |||
| Adalimumab | 50 Participants | |||
| NCT02632175 | Colitis, Ulcerative | Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 | Adalimumab | 47 Participants |
| Adalimumab | 26 Participants | |||
| Adalimumab | 28 Participants | |||
| Adalimumab | 29 Participants | |||
| Adalimumab | 30 Participants | |||
| Adalimumab | 32 Participants | |||
| Adalimumab | 35 Participants | |||
| Adalimumab | 35 Participants | |||
| Adalimumab | 39 Participants | |||
| Adalimumab | 40 Participants | |||
| Adalimumab | 42 Participants | |||
| Adalimumab | 43 Participants | |||
| Adalimumab | 44 Participants | |||
| Adalimumab | 56 Participants | |||
| Adalimumab | 46 Participants | |||
| Adalimumab | 55 Participants | |||
| Adalimumab | 56 Participants | |||
| Adalimumab | 51 Participants | |||
| Adalimumab | 50 Participants | |||
| NCT02632175 | Colitis, Ulcerative | Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 | Adalimumab | 46 Participants |
| Adalimumab | 50 Participants | |||
| Adalimumab | 50 Participants | |||
| Adalimumab | 42 Participants | |||
| Adalimumab | 44 Participants | |||
| Adalimumab | 39 Participants | |||
| Adalimumab | 38 Participants | |||
| Adalimumab | 42 Participants | |||
| Adalimumab | 40 Participants | |||
| Adalimumab | 37 Participants | |||
| Adalimumab | 37 Participants | |||
| Adalimumab | 34 Participants | |||
| Adalimumab | 33 Participants | |||
| Adalimumab | 30 Participants | |||
| Adalimumab | 28 Participants | |||
| Adalimumab | 28 Participants | |||
| Adalimumab | 27 Participants | |||
| Adalimumab | 26 Participants | |||
| Adalimumab | 24 Participants | |||
| NCT02632175 | Colitis, Ulcerative | Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 | Adalimumab | 23 Participants |
| Adalimumab | 38 Participants | |||
| Adalimumab | 43 Participants | |||
| Adalimumab | 42 Participants | |||
| Adalimumab | 30 Participants | |||
| Adalimumab | 27 Participants | |||
| Adalimumab | 25 Participants | |||
| Adalimumab | 26 Participants | |||
| Adalimumab | 49 Participants | |||
| Adalimumab | 21 Participants | |||
| Adalimumab | 47 Participants | |||
| Adalimumab | 32 Participants | |||
| Adalimumab | 34 Participants | |||
| Adalimumab | 36 Participants | |||
| Adalimumab | 37 Participants | |||
| Adalimumab | 37 Participants | |||
| Adalimumab | 47 Participants | |||
| Adalimumab | 40 Participants | |||
| Adalimumab | 39 Participants | |||
| NCT02694523 | Psoriasis | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) Week 16 | Adalimumab (Part A) | 47.4 percentage of participants |
| Risankizumab (Part A) | 72.4 percentage of participants | |||
| NCT02694523 | Psoriasis | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) Week 16 | Adalimumab (Part A) | 60.2 percentage of participants |
| Risankizumab (Part A) | 83.7 percentage of participants | |||
| NCT02694523 | Psoriasis | Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) Week 44 | Adalimumab/Rerandomized to Adalimumab (Part B) | 21.4 percentage of participants |
| Adalimumab/Rerandomized to Risankizumab (Part B) | 66.0 percentage of participants | |||
| NCT02696785 COAST-V | Spondylitis, Ankylosing | Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response Week 16 | Adalimumab | 35.6 percentage of participants |
| IXE80Q2W | 51.8 percentage of participants | |||
| IXE80Q4W | 48.1 percentage of participants | |||
| Placebo | 18.4 percentage of participants | |||
| NCT02744755 ADMYRA | Arthritis, Rheumatoid | Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira Study period 1: week 12 | GP2017 | -2.16 scores on a scale (±0.114 Standard Error) |
| Humira / Switched GP2017 | -2.18 scores on a scale (±0.110 Standard Error) | |||
| NCT02745080 EXCEED 1 | Arthritis, Psoriatic | Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52 Week 52 | Adalimumab 40 mg s.c. | 61.5 Percentage of Participants |
| Secukinumab 300 mg s.c. | 67.4 Percentage of Participants | |||
| NCT02760407 CREDO 2 | Arthritis, Rheumatoid | Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Arm 1: Olokizumab q4w + Methotrexate | 342 Participants |
| Arm 2: Olokizumab q2w + Methotrexate | 326 Participants | |||
| Arm 3: Adalimumab q2w + Methotrexate | 309 Participants | |||
| Arm 4: Placebo q2w + Methotrexate | 108 Participants | |||
| NCT02889796 FINCH 1 | Arthritis, Rheumatoid | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 Week 12 | Adalimumab | 70.5 percentage of participants |
| Filgotinib 100 mg | 69.8 percentage of participants | |||
| Filgotinib 200 mg | 76.6 percentage of participants | |||
| Placebo | 49.9 percentage of participants | |||
| NCT02904902 | Hidradenitis Suppurativa | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 Week 12 | Adalimumab | 86.7 percentage of participants |
| NCT03104400 SELECT - PsA 1 | Psoriasis | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 Baseline and Week 12 | Adalimumab 40 mg | 65.0 percentage of participants |
| Placebo | 36.2 percentage of participants | |||
| Upadacitinib 15 mg | 70.6 percentage of participants | |||
| Upadacitinib 30 mg | 78.5 percentage of participants | |||
| NCT03172325 | — | Percentage of Patients With DAS28-EULAR Good and Moderate Responses at Week 24 Week 24 | AbbVie Adalimumab | 63 percentage of participants |
| CinnaGen Adalimumab | 63 percentage of participants | |||
| NCT03259074 SURPASS | Spondylitis, Ankylosing | Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) Baseline and at Week 104 | AIN457 150 mg/Placebo | 66.1 Percentage of participants |
| AIN457 300 mg | 66.9 Percentage of participants | |||
| GP2017 40mg | 65.6 Percentage of participants | |||
| NCT03412747 BE SURE | Psoriasis | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 Week 16 | Adalimumab (RS) | 47.2 percentage of participants |
| Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | 86.2 percentage of participants | |||
| NCT03412747 BE SURE | Psoriasis | Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16 Week 16 | Adalimumab (RS) | 57.2 percentage of participants |
| Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | 85.3 percentage of participants | |||
| NCT03464136 SEAVUE | Crohn Disease | Percentage of Participants With Clinical Remission at Week 52 Week 52 | Adalimumab | 61.0 percentage of participants |
| Ustekinumab | 64.9 percentage of participants | |||
| NCT03828019 ADVISE | Uveitis | Corticosteroid-sparing Treatment Success Within the First 6 Months After Randomization 6 months | Adalimumab (ADA) | 0.69 Cumulative proportion of participants |
| Conventional Immunosuppression (CON) | 0.54 Cumulative proportion of participants | |||
| NCT03895203 BE OPTIMAL | Arthritis, Psoriatic | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16 Week 16 | ADA 40 mg Q2W | 45.7 percentage of participants |
| BKZ 160 mg Q4W | 43.9 percentage of participants | |||
| Placebo | 10.0 percentage of participants | |||
| NCT03906136 AScalate | Axial Spondyloarthritis | Percentage of Patients Achieving an ASAS40 Response at Week 24 Baseline, Week 24 | Standard-of-care (SOC) | 49.2 Percentage of participants |
| Treat-to-Target (T2T) | 40.1 Percentage of participants | |||
| NCT04088409 | Uveitis | Part A: Percentage of Responders for Baricitinib at Week 24 Week 24 | Baricitinib | 33.3 Percentage of participants |
| NCT04115748 PENGUIN 1 | Arthritis, Psoriatic | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 Week 12 | Adalimumab (Main Study) | 67.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | 63.2 percentage of participants | |||
| Filgotinib 200 mg (Main Study) | 76.8 percentage of participants | |||
| Placebo (Main Study) | 44.8 percentage of participants | |||
| NCT04171414 | Arthritis, Rheumatoid | The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4 Week 4 | "CT-P17 SC AI (Adalimumab)" | 8.23 scores on a scale (±1.191 Standard Deviation) |
| "CT-P17 SC AI (Adalimumab)" | 8.27 scores on a scale (±1.669 Standard Deviation) | |||
| "CT-P17 SC AI (Adalimumab)" | 8.16 scores on a scale (±2.036 Standard Deviation) | |||
| "CT-P17 SC AI (Adalimumab)" | 8.00 scores on a scale (±2.131 Standard Deviation) | |||
| "CT-P17 SC AI (Adalimumab)" | 6.55 scores on a scale (±1.859 Standard Deviation) | |||
| "CT-P17 SC AI (Adalimumab)" | 7.07 scores on a scale (±1.616 Standard Deviation) | |||
| "CT-P17 SC AI (Adalimumab)" | 9.59 scores on a scale (±0.968 Standard Deviation) | |||
| "CT-P17 SC AI (Adalimumab)" | 8.39 scores on a scale (±2.079 Standard Deviation) | |||
| "CT-P17 SC AI (Adalimumab)" | 8.70 scores on a scale (±1.457 Standard Deviation) | |||
| NCT04230213 | Arthritis, Rheumatoid | Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30) | Non-switching Arm: Humira (Adalimumab) | 2365 Micrograms*hour per milliliter (±133 Geometric Coefficient of Variation) |
| Switching Arm: Humira and PF-06410293 (Adalimumab) | 2472 Micrograms*hour per milliliter (±129 Geometric Coefficient of Variation) | |||
| NCT04230213 | Arthritis, Rheumatoid | Maximum Observed Serum Concentration (Cmax) of Adalimumab Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30) | Non-switching Arm: Humira (Adalimumab) | 8.974 Micrograms per milliliter (±97 Geometric Coefficient of Variation) |
| Switching Arm: Humira and PF-06410293 (Adalimumab) | 9.156 Micrograms per milliliter (±97 Geometric Coefficient of Variation) | |||
| NCT04527380 | Arthritis, Juvenile | Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period) Week 16 | Ixekizumab - OLT Period | 88.9 Percentage of participants |
| NCT04909801 | Arthritis, Rheumatoid | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24 Baseline, week 24 | Abatacept | 59.0 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | 60.3 Percentage of participants | |||
| NCT05073315 | — | Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose | Period 2 (Continued-use Group) | 1472.68 hr*μg/mL (±174.9 Geometric Coefficient of Variation) |
| Period 2 (Switching Group) | 1458.03 hr*μg/mL (±156.6 Geometric Coefficient of Variation) | |||
| NCT05073315 | — | Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose | Period 2 (Continued-use Group) | 5.01 μg/mL (±160.4 Geometric Coefficient of Variation) |
| Period 2 (Switching Group) | 4.91 μg/mL (±153.6 Geometric Coefficient of Variation) | |||
| NCT05299242 Anti-FreazeF | Bursitis | Number of Participants Consenting to be Included in the Trial 3 Months | Eligible Participants | 9 Participants |
| NCT05299242 Anti-FreazeF | Bursitis | Number of Participants Eligible With Pain Predominant Frozen Shoulder 3 Months | All Screened Participants | 39 Participants |
| NCT05299242 Anti-FreazeF | Bursitis | Shoulder Pain and Disability Index (SPADI) Score Baseline and 3 months | Adalimumab | 40.1 score on a scale (±30.0 Standard Deviation) |
| Adalimumab | 70.8 score on a scale (±16.6 Standard Deviation) | |||
| Placebo | 45.8 score on a scale (±25.3 Standard Deviation) | |||
| Placebo | 55.4 score on a scale (±21.5 Standard Deviation) | |||
| NCT05299242 Anti-FreazeF | Bursitis | Time From First Injection to Second Injection 6 weeks | Adalimumab | 18.5 days (±3.3 Standard Deviation) |
| Placebo | 20.8 days (±5.9 Standard Deviation) | |||
| NCT05299242 Anti-FreazeF | Bursitis | Time From Randomisation to First Injection 2 weeks | Adalimumab | 12.3 days (±4.8 Standard Deviation) |
| Placebo | 7.2 days (±4.1 Standard Deviation) |