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 |
|---|---|---|---|---|
| NCT00106535 | Arthritis, Rheumatoid | Change From Baseline in Modified Total Sharp-Genant Score at Week 52 Baseline, Week 52 | Placebo + Methotrexate | 1.13 Score on a scale (±2.962 Standard Deviation) |
| Tocilizumab 4 mg/kg + Methotrexate | 0.34 Score on a scale (±1.451 Standard Deviation) | |||
| Tocilizumab 8 mg/kg + Methotrexate | 0.29 Score on a scale (±1.282 Standard Deviation) | |||
| NCT00106535 | Arthritis, Rheumatoid | Change From Baseline in the Modified Total Sharp-Genant Score at Week 104 Baseline, Week 104 | Placebo + Methotrexate | 1.96 Score on a scale (±5.956 Standard Deviation) |
| Tocilizumab 4 mg/kg + Methotrexate | 0.58 Score on a scale (±2.357 Standard Deviation) | |||
| Tocilizumab 8 mg/kg + Methotrexate | 0.37 Score on a scale (±1.547 Standard Deviation) | |||
| NCT00106535 | Arthritis, Rheumatoid | Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52 Baseline to Week 52 | Placebo + Methotrexate | -58.11 Score on a scale*week (±150.839 Full Range) |
| Tocilizumab 4 mg/kg + Methotrexate | -128.37 Score on a scale*week (±165.084 Full Range) | |||
| Tocilizumab 8 mg/kg + Methotrexate | -144.06 Score on a scale*week (±173.372 Full Range) | |||
| NCT00106535 | Arthritis, Rheumatoid | Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104 Baseline to Week 104 | Placebo + Methotrexate | -139.40 Score on a scale*week (±365.682 Full Range) |
| Tocilizumab 4 mg/kg + Methotrexate | -287.50 Score on a scale*week (±383.201 Full Range) | |||
| Tocilizumab 8 mg/kg + Methotrexate | -320.80 Score on a scale*week (±385.741 Full Range) | |||
| NCT00106535 | Arthritis, Rheumatoid | Percentage of Participants With American College of Rheumatology-ACR20 Response Baseline, Week 24 | Placebo + Methotrexate | 27.0 Percentage of participants |
| Tocilizumab 4 mg/kg + Methotrexate | 50.6 Percentage of participants | |||
| Tocilizumab 8 mg/kg + Methotrexate | 56.3 Percentage of participants | |||
| NCT00531817 ROSE | Arthritis, Rheumatoid | Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 Baseline to Week 24 | Placebo + DMARDs | 11.2 Percentage of participants |
| Tocilizumab 8 mg/kg + DMARDs | 30.1 Percentage of participants | |||
| NCT00535782 | Arthritis, Rheumatoid | Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers Baseline and Week 12 | Placebo + MTX | 777.71 nmol/L (±394.527 Standard Deviation) |
| Placebo + MTX | 22.41 nmol/L (±237.476 Standard Deviation) | |||
| Placebo + MTX | 792.78 nmol/L (±392.051 Standard Deviation) | |||
| TCZ + MTX | 23.73 nmol/L (±368.273 Standard Deviation) | |||
| TCZ + MTX | 768.04 nmol/L (±628.281 Standard Deviation) | |||
| TCZ + MTX | 737.79 nmol/L (±467.097 Standard Deviation) | |||
| NCT00535782 | Arthritis, Rheumatoid | Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV) Baseline and Week 12 | Placebo + MTX | 8.39 meters/second (±1.836 Standard Deviation) |
| Placebo + MTX | 9.01 meters/second (±2.519 Standard Deviation) | |||
| Placebo + MTX | -0.68 meters/second (±1.741 Standard Deviation) | |||
| TCZ + MTX | 8.97 meters/second (±1.970 Standard Deviation) | |||
| TCZ + MTX | -0.03 meters/second (±1.970 Standard Deviation) | |||
| TCZ + MTX | 8.94 meters/second (±2.510 Standard Deviation) | |||
| NCT00642460 | Arthritis, Juvenile | Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever Baseline, Week 12 | Placebo | 24.3 Percentage of participants |
| Tocilizumab | 85.3 Percentage of participants | |||
| NCT00642460 | Arthritis, Juvenile | Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104 Baseline, Week 104 | Tocilizumab | 47 Percentage of participants |
| Tocilizumab | 76 Percentage of participants | |||
| Tocilizumab | 73 Percentage of participants | |||
| Tocilizumab | 62 Percentage of participants | |||
| NCT00720798 | Arthritis, Rheumatoid | Percentage of Participants With ≥ 1 Adverse Event Baseline to the end of the study (up to 7 years, 7 months) | Tocilizumab | 96.3 Percentage of participants |
| NCT00721123 | Arthritis, Rheumatoid | Adverse Event (AE) Summary Over Time through 264 Weeks | Months 0 - 12 | 24 Participants |
| Months 0 - 12 | 433 Participants | |||
| Months 0 - 12 | 55 Participants | |||
| Months 13 - 24 | 17 Participants | |||
| Months 13 - 24 | 55 Participants | |||
| Months 13 - 24 | 390 Participants | |||
| Months 25 - 36 | 55 Participants | |||
| Months 25 - 36 | 333 Participants | |||
| Months 25 - 36 | 22 Participants | |||
| Months 37 - 48 | 294 Participants | |||
| Months 37 - 48 | 35 Participants | |||
| Months 37 - 48 | 8 Participants | |||
| Months Greater Than 48 | 32 Participants | |||
| Months Greater Than 48 | 329 Participants | |||
| Months Greater Than 48 | 74 Participants | |||
| NCT00721123 | Arthritis, Rheumatoid | Overall Death Rate Over Time through 264 Weeks | Tocilizumab 8 mg/kg | 0.41 Deaths per 100 PY |
| NCT00721123 | Arthritis, Rheumatoid | Summary Adverse Event Rates Over Time through 264 Weeks | Months 0 - 12 | 0 Adverse Events per 100 Patient Years |
| Months 0 - 12 | 393.76 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 27.35 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 0 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 0.62 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 92.94 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 3.29 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 0.41 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 12.54 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 0.62 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 5.14 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 0.21 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 1.23 Adverse Events per 100 Patient Years | |||
| Months 0 - 12 | 0.21 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 87.52 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 0.22 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 9.90 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 0.90 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 0 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 0.22 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 0 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 1.80 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 0 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 0.45 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 2.47 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 3.82 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 13.05 Adverse Events per 100 Patient Years | |||
| Months 13 - 24 | 286.17 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 5.35 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 0.49 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 260.14 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 5.60 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 5.35 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 87.36 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 0 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 0.49 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 0.73 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 0.24 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 0 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 0.49 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 0.97 Adverse Events per 100 Patient Years | |||
| Months 25 - 36 | 18.74 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 12.62 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 0.77 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 0.77 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 0 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 0.26 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 1.03 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 87.32 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 3.35 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 3.86 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 2.06 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 0.52 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 249.84 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 0.26 Adverse Events per 100 Patient Years | |||
| Months 37 - 48 | 0.26 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 1.50 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 0.68 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 13.12 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 0.27 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 0.68 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 3.55 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 72.82 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 0 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 4.10 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 0.41 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 0 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 4.37 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 212.04 Adverse Events per 100 Patient Years | |||
| Months Greater Than 48 | 0.27 Adverse Events per 100 Patient Years | |||
| NCT00750880 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events (AEs): Overall Summary Weeks 4, 8, 12, 16, 20, and 24 | Tocilizumab 8 mg/kg | 77.4 percentage of participants |
| Tocilizumab 8 mg/kg | 0.4 percentage of participants | |||
| Tocilizumab 8 mg/kg | 0.2 percentage of participants | |||
| Tocilizumab 8 mg/kg | 58.4 percentage of participants | |||
| Tocilizumab 8 mg/kg | 7.8 percentage of participants | |||
| Tocilizumab 8 mg/kg | 7.8 percentage of participants | |||
| Tocilizumab 8 mg/kg | 3.5 percentage of participants | |||
| Tocilizumab 8 mg/kg | 5.1 percentage of participants | |||
| Tocilizumab 8 mg/kg | 10.8 percentage of participants | |||
| Tocilizumab 8 mg/kg | 35.3 percentage of participants | |||
| Tocilizumab 8 mg/kg | 2.1 percentage of participants | |||
| Tocilizumab 8 mg/kg | 17.3 percentage of participants | |||
| Tocilizumab 8 mg/kg | 6.7 percentage of participants | |||
| Tocilizumab 8 mg/kg | 12.6 percentage of participants | |||
| NCT00754559 | Arthritis, Rheumatoid | Percentage of Participants With Low Disease Activity Score at Week 24 Week 24 | Tocilizumab | 57 Percentage of Participants |
| NCT00754572 | Arthritis, Rheumatoid | Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24 Week 24 | Tocilizumab | 73.23 percentage of participants |
| NCT00773461 | Arthritis, Rheumatoid | Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24 Week 24 | Placebo + DMARDs | 24.6 Percentage of Participants |
| Placebo + DMARDs | 24.6 Percentage of Participants | |||
| Tocilizumab + DMARDs | 73.4 Percentage of Participants | |||
| Tocilizumab + DMARDs | 69.8 Percentage of Participants | |||
| NCT00810199 | Arthritis, Rheumatoid | Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24 Week 24 | Tocilizumab + Methotrexate | 40.4 Percentage of participants |
| Tocilizumab + Placebo | 34.8 Percentage of participants | |||
| NCT00810277 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) Baseline up to Week 24 | Tocilizumab | 7.1 percentage of participants |
| Tocilizumab | 92.9 percentage of participants | |||
| NCT00848120 | Arthritis, Rheumatoid | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24 Week 24 | Tocilizumab 8 mg/kg | 86 percentage of participants |
| NCT00883753 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) 108 Weeks | Tocilizumab + > 1 DMARD | 7.3 percentage of participants |
| Tocilizumab + > 1 DMARD | 73.2 percentage of participants | |||
| Tocilizumab + 1 DMARD | 5.7 percentage of participants | |||
| Tocilizumab + 1 DMARD | 68.6 percentage of participants | |||
| Tocilizumab Monotherapy | 65.0 percentage of participants | |||
| Tocilizumab Monotherapy | 8.5 percentage of participants | |||
| NCT00891020 | Arthritis, Rheumatoid | Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period 24 Weeks | Tocilizumab 4 mg/kg + DMARD | 8.0 Percentage of Participants |
| Tocilizumab 8 mg/kg + DMARD | 8.4 Percentage of Participants | |||
| Tocilizumab 8 mg/kg Monotherapy | 5.8 Percentage of Participants | |||
| NCT00951275 | Arthritis, Rheumatoid | Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores Week 4 | Tocilizumab 8 mg/kg | 8.76 units on a scale (±8.83 Standard Deviation) |
| NCT00951275 | Arthritis, Rheumatoid | Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin Week 4 | Tocilizumab 8 mg/kg | 0.40 g/dL (±0.78 Standard Deviation) |
| NCT00977106 | Arthritis, Rheumatoid | Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4 Week 4 | Placebo, Tocilizumab | 42.0 percentage of participants |
| Tocilizumab | 49.1 percentage of participants | |||
| NCT00988221 | Arthritis, Juvenile | Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40) Week 16 through Week 40 | Placebo | 48.1 Percent of patients |
| Tocilizumab 8 or 10 mg/kg | 25.6 Percent of patients | |||
| NCT00996606 | Arthritis, Rheumatoid | Change From Baseline to Week 4 in Synovitis of the Wrist According to Rate of Early Enhancement (REE) Per Second Before and After Contrast Injection Baseline and Week 4 | Tocilizumab in Active RA | -0.10 percent rate of early enhancement (±0.86 Standard Deviation) |
| Tocilizumab in Active RA | 1.19 percent rate of early enhancement (±1.04 Standard Deviation) | |||
| NCT00996606 | Arthritis, Rheumatoid | Change From Baseline to Week 4 in Synovitis of the Wrist According to Relative Enhancement (RE) Before and After Contrast Injection Baseline and Week 4 | Tocilizumab in Active RA | 99.25 percent relative enhancement (±57.85 Standard Deviation) |
| Tocilizumab in Active RA | -0.48 percent relative enhancement (±47.85 Standard Deviation) | |||
| NCT00996606 | Arthritis, Rheumatoid | Change From Baseline to Week 4 in Synovitis of the Wrist According to Rheumatoid Arthritis Magnetic Resonance Imaging (RAMRIS) Score Baseline and Week 4 | Tocilizumab in Active RA | -0.88 units on a scale (±1.56 Standard Deviation) |
| Tocilizumab in Active RA | 5.78 units on a scale (±2.72 Standard Deviation) | |||
| NCT01007435 | Arthritis, Rheumatoid | Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24 Week 24 | Placebo to Tocilizumab + Methotrexate | 15.0 Percentage of participants |
| Tocilizumab 4 mg/kg + Methotrexate | 31.9 Percentage of participants | |||
| Tocilizumab 8 mg/kg + Methotrexate | 44.8 Percentage of participants | |||
| Tocilizumab 8 mg/kg + Placebo to Methotrexate | 38.7 Percentage of participants | |||
| NCT01034137 | Arthritis, Rheumatoid | Percentage of Participants Achieving Sustained Remission Rate At Week 104 Week 104 | Methotrexate + Placebo Tocilizumab | 44.4 Percentage of participants |
| Tocilizumab + Methotrexate | 85.8 Percentage of participants | |||
| Tocilizumab + Placebo Methotrexate | 83.5 Percentage of participants | |||
| NCT01044498 | Arthritis, Rheumatoid | Serum Progesterone Level Day 21 of Cycles 1-3 for Group 1 and Day 21 of Cycle 1 for Group 2 | Ortho-Novum® 1/35 (Group 2) | NA ng/mL (±NA Standard Deviation) |
| Ortho-Novum® 1/35 (Group 2) | NA ng/mL (±NA Standard Deviation) | |||
| Ortho-Novum® 1/35 (Group 2) | 0.57 ng/mL (±0.39 Standard Deviation) | |||
| Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1) | 0.22 ng/mL (±0.10 Standard Deviation) | |||
| Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1) | 0.19 ng/mL (±0.00 Standard Deviation) | |||
| Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1) | 0.21 ng/mL (±0.07 Standard Deviation) | |||
| NCT01063062 | Arthritis, Rheumatoid | Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24) | Tocilizumab | 34.48 percentage of participants |
| Tocilizumab | 34.48 percentage of participants | |||
| Tocilizumab | 27.59 percentage of participants | |||
| Tocilizumab | 58.62 percentage of participants | |||
| Tocilizumab | 44.83 percentage of participants | |||
| Tocilizumab | 62.07 percentage of participants | |||
| Tocilizumab + MTX | 47.37 percentage of participants | |||
| Tocilizumab + MTX | 18.42 percentage of participants | |||
| Tocilizumab + MTX | 40.79 percentage of participants | |||
| Tocilizumab + MTX | 38.16 percentage of participants | |||
| Tocilizumab + MTX | 57.89 percentage of participants | |||
| Tocilizumab + MTX | 59.21 percentage of participants | |||
| NCT01063062 | Arthritis, Rheumatoid | Time to DAS28 Low Disease Activity 24 Weeks | Tocilizumab | 107.2 days |
| Tocilizumab + MTX | 100.2 days | |||
| NCT01194414 | Arthritis, Rheumatoid | Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24 Baseline, 24 weeks | Tocilizumab IV | 73.4 Percentage of participants |
| Tocilizumab SC | 69.4 Percentage of participants | |||
| NCT01194414 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments Baseline to up to 3 months after last dose of study drug (approximately up to 2 years) | Tocilizumab IV | 87.8 percentage of participants |
| Tocilizumab IV | 28.2 percentage of participants | |||
| Tocilizumab IV | 12.7 percentage of participants | |||
| Tocilizumab IV Then Tocilizumab SC | 86.6 percentage of participants | |||
| Tocilizumab IV Then Tocilizumab SC | 11.3 percentage of participants | |||
| Tocilizumab IV Then Tocilizumab SC | 19.4 percentage of participants | |||
| Tocilizumab SC | 37.7 percentage of participants | |||
| Tocilizumab SC | 91.6 percentage of participants | |||
| Tocilizumab SC | 13.9 percentage of participants | |||
| Tocilizumab SC Then Tocilizumab IV | 81.3 percentage of participants | |||
| Tocilizumab SC Then Tocilizumab IV | 25.0 percentage of participants | |||
| Tocilizumab SC Then Tocilizumab IV | 12.5 percentage of participants | |||
| NCT01209689 | Spondylitis, Ankylosing | Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12 Baseline to Week 12 | Placebo | 14.3 Percentage of patients |
| Tocilizumab 4 or 8 mg/kg | 12.7 Percentage of patients | |||
| NCT01209702 | Spondylitis, Ankylosing | Part 1: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12 Baseline and Week 12 | Part 1: Placebo | 27.5 percentage of participants |
| Part 1: Tocilizumab | 37.3 percentage of participants | |||
| NCT01209702 | Spondylitis, Ankylosing | Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12 Baseline and Week 12 | Part 2: Placebo | 7.8 percentage of participants |
| Part 2: Tocilizumab | 9.2 percentage of participants | |||
| NCT01232569 | Arthritis, Rheumatoid | Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 Baseline to Week 24 | Placebo sc | 31.5 Percentage of patients |
| Tocilizumab 162 mg sc | 60.9 Percentage of patients | |||
| NCT01235507 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24 | Tocilizumab Plus MTX | 4.2 percentage of participants |
| Tocilizumab Plus MTX | 14.1 percentage of participants | |||
| Tocilizumab Plus MTX | 2.8 percentage of participants | |||
| NCT01245439 | Arthritis, Rheumatoid | Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events 24 weeks | Tocilizumab 8 mg/kg | 9.2 percentage of participants |
| Tocilizumab 8 mg/kg | 90.8 percentage of participants | |||
| Tocilizumab 8 mg/kg | 52.3 percentage of participants | |||
| NCT01254331 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death Baseline, every 4 weeks through Week 52 | Tocilizumab | 0 percentage of participants |
| Tocilizumab | 78.4 percentage of participants | |||
| Tocilizumab | 5.9 percentage of participants | |||
| Tocilizumab | 15.2 percentage of participants | |||
| Tocilizumab | 7.8 percentage of participants | |||
| NCT01326962 | Arthritis, Rheumatoid | Change in Fatigue as Measured Using the Fatigue Visual Analog Scale Up to 1 year | Tocilizumab | 14.4 units on a scale |
| Tocilizumab | 20.1 units on a scale | |||
| Tocilizumab | 29.0 units on a scale | |||
| Tocilizumab | 32.3 units on a scale | |||
| Tocilizumab | 38.1 units on a scale | |||
| Tocilizumab | 32.0 units on a scale | |||
| Tocilizumab | 26.3 units on a scale | |||
| Tocilizumab | 23.9 units on a scale | |||
| Tocilizumab | 19.1 units on a scale | |||
| Tocilizumab | 20.7 units on a scale | |||
| Tocilizumab | 13.1 units on a scale | |||
| Tocilizumab | 18.0 units on a scale | |||
| NCT01326962 | Arthritis, Rheumatoid | Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score Up to 1 year | Tocilizumab | 19.1 Units on a scale |
| Tocilizumab | 23.5 Units on a scale | |||
| Tocilizumab | 24.1 Units on a scale | |||
| Tocilizumab | 23.6 Units on a scale | |||
| Tocilizumab | 24.0 Units on a scale | |||
| Tocilizumab | 21.6 Units on a scale | |||
| Tocilizumab | 22.0 Units on a scale | |||
| Tocilizumab | 22.3 Units on a scale | |||
| Tocilizumab | 27.8 Units on a scale | |||
| Tocilizumab | 27.3 Units on a scale | |||
| Tocilizumab | 26.6 Units on a scale | |||
| Tocilizumab | 25.6 Units on a scale | |||
| NCT01326962 | Arthritis, Rheumatoid | Disease Activity as Measured by Disease Activity Score 28 (DAS28) Up to 1 year | Tocilizumab | 2.0 units on a scale |
| Tocilizumab | 2.3 units on a scale | |||
| Tocilizumab | 5.4 units on a scale | |||
| Tocilizumab | 3.5 units on a scale | |||
| Tocilizumab | 2.1 units on a scale | |||
| Tocilizumab | 2.8 units on a scale | |||
| Tocilizumab | 2.2 units on a scale | |||
| Tocilizumab | 1.9 units on a scale | |||
| Tocilizumab | 1.7 units on a scale | |||
| Tocilizumab | 1.7 units on a scale | |||
| Tocilizumab | 1.5 units on a scale | |||
| Tocilizumab | 1.9 units on a scale | |||
| Tocilizumab | 1.7 units on a scale | |||
| NCT01326962 | Arthritis, Rheumatoid | Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units) Up to 1 year | Tocilizumab | 11 participants |
| Tocilizumab | 21 participants | |||
| Tocilizumab | 20 participants | |||
| Tocilizumab | 20 participants | |||
| Tocilizumab | 22 participants | |||
| Tocilizumab | 21 participants | |||
| Tocilizumab | 20 participants | |||
| Tocilizumab | 19 participants | |||
| Tocilizumab | 20 participants | |||
| Tocilizumab | 17 participants | |||
| Tocilizumab | 12 participants | |||
| Tocilizumab | 4 participants | |||
| NCT01326962 | Arthritis, Rheumatoid | Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response Up to 1 year | Tocilizumab | 4 participants |
| Tocilizumab | 5 participants | |||
| Tocilizumab | 4 participants | |||
| Tocilizumab | 3 participants | |||
| Tocilizumab | 4 participants | |||
| Tocilizumab | 2 participants | |||
| Tocilizumab | 7 participants | |||
| Tocilizumab | 7 participants | |||
| Tocilizumab | 6 participants | |||
| Tocilizumab | 6 participants | |||
| Tocilizumab | 6 participants | |||
| NCT01326962 | Arthritis, Rheumatoid | Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2) Up to 1 year | Tocilizumab | 7 participants |
| Tocilizumab | 7 participants | |||
| Tocilizumab | 7 participants | |||
| Tocilizumab | 4 participants | |||
| Tocilizumab | 3 participants | |||
| Tocilizumab | 3 participants | |||
| Tocilizumab | 2 participants | |||
| Tocilizumab | 2 participants | |||
| Tocilizumab | 9 participants | |||
| Tocilizumab | 4 participants | |||
| Tocilizumab | 1 participants | |||
| Tocilizumab | 0 participants | |||
| NCT01326962 | Arthritis, Rheumatoid | Number of Participants Who Achieved Remission (DAS28 < 2.6) Up to 1 year | Tocilizumab | 7 participants |
| Tocilizumab | 15 participants | |||
| Tocilizumab | 4 participants | |||
| Tocilizumab | 8 participants | |||
| Tocilizumab | 18 participants | |||
| Tocilizumab | 13 participants | |||
| Tocilizumab | 3 participants | |||
| Tocilizumab | 7 participants | |||
| Tocilizumab | 12 participants | |||
| Tocilizumab | 14 participants | |||
| Tocilizumab | 17 participants | |||
| Tocilizumab | 16 participants | |||
| NCT01326962 | Arthritis, Rheumatoid | Time to Das28 Remission Up to 1 year | Tocilizumab | 189.01 Day (±7.053 Standard Error) |
| NCT01332994 | Arthritis, Rheumatoid | Percentage of Participants Achieving Remission at Week 16 According to DAS28 Week 16 | TCZ/TCZ or TCZ/RTX | 42.8 percentage of participants |
| NCT01353859 | Arthritis, Rheumatoid | Percentage of Participants Achieving Low Disease Activity Score Week 24 | Tocilizumab + MTX | 100 percentage of participants |
| NCT01532869 | Scleroderma, Systemic | Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 Baseline, Week 24 | Placebo | -1.22 unit on a scale |
| Tocilizumab | -3.92 unit on a scale | |||
| NCT01532869 | Scleroderma, Systemic | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Week 48 | Placebo | 90.9 percentage of participants |
| Placebo | 34.1 percentage of participants | |||
| Tocilizumab | 97.7 percentage of participants | |||
| Tocilizumab | 32.6 percentage of participants | |||
| NCT01575769 | Arthritis, Juvenile | Percentage of Participants With Adverse Events (AEs) Baseline to 12 weeks after last actual study medication (up to 101 weeks) | Tocilizumab | 0.0 percentage of participants |
| Tocilizumab | 22.0 percentage of participants | |||
| Tocilizumab | 0.0 percentage of participants | |||
| Tocilizumab | 2.4 percentage of participants | |||
| Tocilizumab | 0.0 percentage of participants | |||
| Tocilizumab | 2.4 percentage of participants | |||
| Tocilizumab | 56.1 percentage of participants | |||
| Tocilizumab | 29.3 percentage of participants | |||
| Tocilizumab | 7.3 percentage of participants | |||
| Tocilizumab | 2.4 percentage of participants | |||
| NCT01587989 | Arthritis, Rheumatoid | Change From Week 12 (Randomization) to Week 24 in DAS28 Weeks 12 and 24 | Group A: TCZ + MTX | 0.17 score on a scale (±0.83 Standard Deviation) |
| Group B: TCZ + Placebo | -0.16 score on a scale (±1.13 Standard Deviation) | |||
| NCT01610791 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Tocilizumab 8 mg/kg | 0.8 percentage of participants |
| Tocilizumab 8 mg/kg | 8.3 percentage of participants | |||
| Tocilizumab 8 mg/kg | 48.8 percentage of participants | |||
| Tocilizumab 8 mg/kg | 10.7 percentage of participants | |||
| Tocilizumab 8 mg/kg | 5.8 percentage of participants | |||
| Tocilizumab 8 mg/kg | 10.7 percentage of participants | |||
| Tocilizumab 8 mg/kg | 4.1 percentage of participants | |||
| Tocilizumab 8 mg/kg | 5.0 percentage of participants | |||
| NCT01649804 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) End of Study (Week 104 or early withdrawal) | Tocilizumab | 75 percentage of participants |
| Tocilizumab | 0 percentage of participants | |||
| Tocilizumab | 0 percentage of participants | |||
| NCT01655381 | Arthritis, Rheumatoid | Percentage of Participants With Any Adverse Event (AE) Up to 160 weeks | Tocilizumab | 6.7 percentage of participants |
| Tocilizumab | 0 percentage of participants | |||
| Tocilizumab | 20.0 percentage of participants | |||
| Tocilizumab | 20.0 percentage of participants | |||
| Tocilizumab | 80.0 percentage of participants | |||
| Tocilizumab | 80.0 percentage of participants | |||
| Tocilizumab | 93.3 percentage of participants | |||
| Tocilizumab | 6.7 percentage of participants | |||
| Tocilizumab | 0 percentage of participants | |||
| Tocilizumab | 33.3 percentage of participants | |||
| Tocilizumab | 93.3 percentage of participants | |||
| NCT01662063 | Arthritis, Rheumatoid | Number of Participants With at Least One Serious Adverse Event (SAE) From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall) | SC TCZ Q2W | 4 participants |
| SC TCZ QW | 19 participants | |||
| NCT01662063 | Arthritis, Rheumatoid | Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall) | SC TCZ Q2W | 4.5 percentage of participants |
| SC TCZ QW | 7.8 percentage of participants | |||
| NCT01662063 | Arthritis, Rheumatoid | Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline Baseline | SC TCZ Q2W | 2.3 percentage of participants |
| SC TCZ QW | 4.8 percentage of participants | |||
| NCT01662063 | Arthritis, Rheumatoid | Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall) | SC TCZ Q2W | 0 percentage of participants |
| SC TCZ Q2W | 0 percentage of participants | |||
| SC TCZ Q2W | 2.3 percentage of participants | |||
| SC TCZ QW | 0.6 percentage of participants | |||
| SC TCZ QW | 3.0 percentage of participants | |||
| SC TCZ QW | 0.6 percentage of participants | |||
| NCT01662063 | Arthritis, Rheumatoid | Percentage of Participants With at Least One SAE From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall) | SC TCZ Q2W | 9.1 percentage of participants |
| SC TCZ QW | 11.0 percentage of participants | |||
| NCT01664598 | Arthritis, Rheumatoid | Percentage of Adverse Events (AEs) Leading to Dose Modification and AEs Leading to Study Withdrawal Up to 112 weeks | Tocilizumab | 1.1 percentage of adverse events |
| Tocilizumab | 34.5 percentage of adverse events | |||
| NCT01664598 | Arthritis, Rheumatoid | Percentage of Adverse Events With Severity as Mild, Moderate, and Severe Up to 112 weeks | Tocilizumab | 62.1 percentage of adverse events |
| Tocilizumab | 1.1 percentage of adverse events | |||
| Tocilizumab | 36.8 percentage of adverse events | |||
| NCT01664598 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs) Up to 112 weeks | Tocilizumab | 17.2 percentage of participants |
| Tocilizumab | 10.2 percentage of participants | |||
| Tocilizumab | 69.4 percentage of participants | |||
| NCT01665430 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events (AEs), AEs of Special Interest and Serious Adverse Events (SAEs) Baseline up to 112 weeks | Tocilizumab | 34.2 percentage of participants |
| Tocilizumab | 7.9 percentage of participants | |||
| Tocilizumab | 65.8 percentage of participants | |||
| NCT01667471 | Arthritis, Juvenile | Number of AEs of Special Interest and Study Drug Related AEs Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks) | Tocilizumab 8 mg/kg | 2 adverse events |
| Tocilizumab 8 mg/kg | 2 adverse events | |||
| Tocilizumab 8 mg/kg | 0 adverse events | |||
| Tocilizumab 8 mg/kg | 22 adverse events | |||
| NCT01667471 | Arthritis, Juvenile | Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks) | Tocilizumab | 6 participants |
| Tocilizumab | 1 participants | |||
| Tocilizumab | 0 participants | |||
| Tocilizumab | 1 participants | |||
| NCT01668966 | Arthritis, Rheumatoid | Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation Baseline up to approximately 104 weeks | Tocilizumab | 28.6 percentage of participants |
| Tocilizumab | 4.8 percentage of participants | |||
| NCT01668966 | Arthritis, Rheumatoid | Percentage of Participants With TEAEs of Special Interest Baseline up to approximately 104 weeks | Tocilizumab | 95.2 percentage of participants |
| NCT01668966 | Arthritis, Rheumatoid | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Baseline up to approximately 104 weeks | Tocilizumab | 9.5 percentage of participants |
| Tocilizumab | 95.2 percentage of participants | |||
| NCT01673919 | Arthritis, Juvenile | Number of Participants With Adverse Events of Special Interest Approximately 2 years | Tocilizumab (8 mg/kg) | 1 participants |
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 2 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 2 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| Tocilizumab (8 mg/kg) | 1 participants | |||
| NCT01673919 | Arthritis, Juvenile | Number of Participants With Adverse Events Related to Tocilizumab Approximately 2 years | Tocilizumab (8 mg/kg) | 1 participants |
| Tocilizumab (8 mg/kg) | 5 participants | |||
| Tocilizumab (8 mg/kg) | 2 participants | |||
| NCT01673919 | Arthritis, Juvenile | Number of Participants With Any Adverse Events and Any Serious Adverse Events Approximately 2 years | Tocilizumab (8 mg/kg) | 0 participants |
| Tocilizumab (8 mg/kg) | 7 participants | |||
| NCT01734993 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to approximately 142 weeks | Tocilizumab | 100 Percentage of participants |
| Tocilizumab | 18.2 Percentage of participants | |||
| NCT01734993 | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events of Special Interest (AESIs) Baseline up to approximately 142 weeks | Tocilizumab | 18.2 Percentage of participants |
| NCT01734993 | Arthritis, Rheumatoid | Percentage of Participants With AEs and SAEs Related to TCZ Baseline up to approximately 142 weeks | Tocilizumab | 9.1 Percentage of participants |
| Tocilizumab | 72.7 Percentage of participants | |||
| NCT01734993 | Arthritis, Rheumatoid | Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification Baseline up to approximately 142 weeks | Tocilizumab | 63.6 Percentage of participants |
| Tocilizumab | 0.0 Percentage of participants | |||
| Tocilizumab | 9.1 Percentage of participants | |||
| NCT01734993 | Arthritis, Rheumatoid | Percentage of Participants With AESIs Related to TCZ Baseline up to approximately 142 weeks | Tocilizumab | 18.2 Percentage of participants |
| NCT01734993 | Arthritis, Rheumatoid | Percentage of Participants With Anti-TCZ Antibodies Baseline up to approximately 142 weeks | Tocilizumab | 0.0 Percentage of participants |
| NCT01734993 | Arthritis, Rheumatoid | Percentage of Participants With Clinically Significant Laboratory Abnormalities Baseline up to approximately 142 weeks | Tocilizumab | 9.1 Percentage of participants |
| NCT01734993 | Arthritis, Rheumatoid | Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities Baseline up to approximately 142 weeks | Tocilizumab | 0.0 Percentage of participants |
| NCT01768572 | Arthritis, Rheumatoid | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Up to 211 days | Sarilumab 150 mg q2w | 1 participants |
| Sarilumab 150 mg q2w | 33 participants | |||
| Sarilumab 150 mg q2w | 6 participants | |||
| Sarilumab 150 mg q2w | 0 participants | |||
| Sarilumab 200 mg q2w | 36 participants | |||
| Sarilumab 200 mg q2w | 8 participants | |||
| Sarilumab 200 mg q2w | 0 participants | |||
| Sarilumab 200 mg q2w | 3 participants | |||
| Tocilizumab q4w | 68 participants | |||
| Tocilizumab q4w | 1 participants | |||
| Tocilizumab q4w | 4 participants | |||
| Tocilizumab q4w | 7 participants | |||
| NCT01772316 | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 96 Baseline, Week 96 | Tocilizumab Subcutaneous (SC) | -0.804 units on a scale (±0.230 Standard Deviation) |
| NCT01772316 | Arthritis, Rheumatoid | Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48 Baseline, Week 48 | Tocilizumab Subcutaneous (SC) | -0.832 units on a scale (±0.292 Standard Deviation) |
| Tocilizumab Subcutaneous (SC) | 2.9 units on a scale (±1.4 Standard Deviation) | |||
| NCT01772316 | Arthritis, Rheumatoid | Change From Baseline in SDAI at Week 96 Baseline, Week 96 | Tocilizumab Subcutaneous (SC) | -6.599 units on a scale (±2.210 Standard Deviation) |
| NCT01772316 | Arthritis, Rheumatoid | Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 48 Baseline, Week 48 | Tocilizumab Subcutaneous (SC) | -7.572 units on a scale (±2.115 Standard Deviation) |
| Tocilizumab Subcutaneous (SC) | 12.2 units on a scale (±10.7 Standard Deviation) | |||
| NCT01772316 | Arthritis, Rheumatoid | Change From Baseline in SJC at Week 96 Baseline, Week 96 | Tocilizumab Subcutaneous (SC) | -1.188 units on a scale (±0.543 Standard Deviation) |
| NCT01772316 | Arthritis, Rheumatoid | Change From Baseline in Swollen Joint Count (SJC) at Week 48 Baseline, Week 48 | Tocilizumab Subcutaneous (SC) | -1.531 units on a scale (±0.587 Standard Deviation) |
| Tocilizumab Subcutaneous (SC) | 1.8 units on a scale (±3.4 Standard Deviation) | |||
| NCT01772316 | Arthritis, Rheumatoid | Change From Baseline in Total Tender Joint Count (TJC) at Week 48 Baseline, Week 48 | Tocilizumab Subcutaneous (SC) | 2.5 units on a scale (±4.1 Standard Deviation) |
| Tocilizumab Subcutaneous (SC) | 1.3 units on a scale (±2.0 Standard Deviation) | |||
| NCT01772316 | Arthritis, Rheumatoid | Change From Baseline in Total TJC at Week 96 Baseline, Week 96 | Tocilizumab Subcutaneous (SC) | 1.5 units on a scale (±3.6 Standard Deviation) |
| NCT01772316 | Arthritis, Rheumatoid | Percentage of Participants With an Adverse Event (AE) Baseline up to follow-up (Week 104) | Tocilizumab Subcutaneous (SC) | 83 percentage of participants |
| NCT01772316 | Arthritis, Rheumatoid | Percentage of Participants Withdrawn From the Study Due to Lack of Therapeutic Response Baseline up to follow-up (Week 104) | Tocilizumab Subcutaneous (SC) | 0 percentage of participants |
| NCT01791153 | Giant Cell Arteritis | Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) Week 52 | Part 1: Placebo + 26 Weeks Prednisone Taper | 14.0 percentage of participants |
| Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 53.1 percentage of participants | |||
| Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 56.0 percentage of participants | |||
| NCT01855789 | Arthritis, Rheumatoid | Change From Week 24 in Disease Activity Score Based on 28 Joints (DAS28) Score at Week 40 Week 24, Week 40 | Period 2: Randomized Participants (TCZ + MTX) | 2.13 units on a scale (±0.816 Standard Deviation) |
| Period 2: Randomized Participants (TCZ + MTX) | 0.15 units on a scale (±1.127 Standard Deviation) | |||
| Period 2: Randomized Participants (TCZ + PBO) | 2.11 units on a scale (±0.822 Standard Deviation) | |||
| Period 2: Randomized Participants (TCZ + PBO) | 0.48 units on a scale (±1.275 Standard Deviation) | |||
| NCT01941095 | Arthritis, Rheumatoid | Percentage of Participants Who Achieved Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at Week 24 Week 24 | Tocilizumab | 40 percentage of participants |
| NCT01941940 | Arthritis, Rheumatoid | Change From Baseline in CDAI at Week 12 Baseline, Week 12 | Tocilizumab | -19.1 units on a scale (±12.46 Standard Deviation) |
| NCT01941940 | Arthritis, Rheumatoid | Change From Baseline in CDAI at Week 16 Baseline, Week 16 | Tocilizumab | -20.2 units on a scale (±12.53 Standard Deviation) |
| NCT01941940 | Arthritis, Rheumatoid | Change From Baseline in CDAI at Week 2 Baseline, Week 2 | Tocilizumab | -9.1 units on a scale (±9.71 Standard Deviation) |
| NCT01941940 | Arthritis, Rheumatoid | Change From Baseline in CDAI at Week 20 Baseline, Week 20 | Tocilizumab | -21.3 units on a scale (±12.87 Standard Deviation) |
| NCT01941940 | Arthritis, Rheumatoid | Change From Baseline in CDAI at Week 4 Baseline, Week 4 | Tocilizumab | -14.0 units on a scale (±11.57 Standard Deviation) |
| NCT01941940 | Arthritis, Rheumatoid | Change From Baseline in CDAI at Week 8 Baseline, Week 8 | Tocilizumab | -17.7 units on a scale (±12.07 Standard Deviation) |
| NCT01941940 | Arthritis, Rheumatoid | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24 Baseline, Week 24 | Tocilizumab | -21.6 units on a scale (±13.25 Standard Deviation) |
| NCT01951170 | Arthritis, Rheumatoid | Change From Baseline in Genant-modified Total Sharp Score (mTSS) From baseline to Week 24 | Tocilizumab | 0 units on a scale |
| Tocilizumab | 7.00 units on a scale | |||
| NCT01987479 OSCAR | Arthritis, Rheumatoid | Percentage of Participants With Adverse Events Baseline up to Week 32 | Tocilizumab Alone or in Combination With Methotrexate or DMARD | 91.3 percentage of participants |
| NCT01988012 | Arthritis, Rheumatoid | Change From Baseline in CDAI Baseline, Week 24 | Tocilizumab | 31.89 units on a scale (±14.35 Standard Deviation) |
| Tocilizumab | -18.29 units on a scale (±14.52 Standard Deviation) | |||
| NCT01988012 | Arthritis, Rheumatoid | Change From Baseline in Disease Activity Score 28-Erythrocyte-Sedimentation Rate (DAS28-ESR) Baseline, Week 24 | Tocilizumab | -2.47 units on a scale (±1.29 Standard Deviation) |
| Tocilizumab | 4.98 units on a scale (±0.98 Standard Deviation) | |||
| NCT01988012 | Arthritis, Rheumatoid | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Baseline, Week 24 | Tocilizumab | -0.34 units on a scale (±0.62 Standard Deviation) |
| Tocilizumab | 1.55 units on a scale (±0.80 Standard Deviation) | |||
| NCT01988012 | Arthritis, Rheumatoid | Change From Baseline in Patient Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Baseline, Week 24 | Tocilizumab | 23.46 units on a scale (±11.32 Standard Deviation) |
| Tocilizumab | 6.95 units on a scale (±9.70 Standard Deviation) | |||
| NCT01988012 | Arthritis, Rheumatoid | Change From Baseline in Patient Global Assessment of Disease Activity Visual Analog Scale (PGA VAS) Baseline, Week 24 | Tocilizumab | 69.73 units on a scale (±24.55 Standard Deviation) |
| Tocilizumab | -31.22 units on a scale (±28.43 Standard Deviation) | |||
| NCT01988012 | Arthritis, Rheumatoid | Change From Baseline in Patient Pain VAS Baseline, Week 24 | Tocilizumab | 64.82 units on a scale (±26.39 Standard Deviation) |
| Tocilizumab | -29.11 units on a scale (±29.16 Standard Deviation) | |||
| NCT01988012 | Arthritis, Rheumatoid | Change From Baseline in Percentage of Participants on Tocilizumab Monotherapy Baseline, Week 24 | Tocilizumab | 12 percentage of participants |
| Tocilizumab | 26 percentage of participants | |||
| NCT01988012 | Arthritis, Rheumatoid | Change From Baseline in SDAI Baseline, Week 24 | Tocilizumab | 33.73 units on a scale (±14.83 Standard Deviation) |
| Tocilizumab | -21.41 units on a scale (±14.99 Standard Deviation) | |||
| NCT01988012 | Arthritis, Rheumatoid | Change From Baseline in TJC and SJC Baseline, Week 24 | Tocilizumab | -7.54 joint count (±9.60 Standard Deviation) |
| Tocilizumab | 21.42 joint count (±15.20 Standard Deviation) | |||
| Tocilizumab | -11.91 joint count (±13.59 Standard Deviation) | |||
| Tocilizumab | 10.30 joint count (±10.27 Standard Deviation) | |||
| NCT01988012 | Arthritis, Rheumatoid | Percentage of Participants Achieving 20%, 50% and 70% Improvement in American College of Rheumatology (ACR) Response Scores (ACR20, ACR50 and ACR70) Week 24 | Tocilizumab | 20.0 percentage of participants |
| Tocilizumab | 62.4 percentage of participants | |||
| Tocilizumab | 37.6 percentage of participants | |||
| NCT01988012 | Arthritis, Rheumatoid | Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission and CDAI Low Disease Activity Week 24 | Tocilizumab | 16.5 percentage of participants |
| Tocilizumab | 34.1 percentage of participants | |||
| NCT01988012 | Arthritis, Rheumatoid | Percentage of Participants With Good to Moderate European League Against Rheumatism (EULAR) Response Week 24 | Tocilizumab | 96.4 percentage of participants |
| NCT01988012 | Arthritis, Rheumatoid | Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission and SDAI Low Disease Activity Week 24 | Tocilizumab | 19.2 percentage of participants |
| Tocilizumab | 38.5 percentage of participants | |||
| NCT01988012 | Arthritis, Rheumatoid | Total Scores on Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Scale (HAS) Baseline, Week 24 | Tocilizumab | 4.94 units on a scale (±5.85 Standard Deviation) |
| Tocilizumab | 5.93 units on a scale (±7.17 Standard Deviation) | |||
| Tocilizumab | 7.87 units on a scale (±7.19 Standard Deviation) | |||
| Tocilizumab | 8.56 units on a scale (±8.43 Standard Deviation) | |||
| NCT01995201 | Arthritis, Rheumatoid | Percentage of Participants Achieving Sustained Clinical Remission, Disease Activity Scale 28 - Erythrocyte Sedimentation Rate <26 (DAS28-ESR <2.6) at Week 20 and Week 24 Week 20 and Week 24 | Phase 1: Combination Therapy | 52.9 Percentage of participants |
| Phase 1: Tocilizumab Monotherapy | 48.4 Percentage of participants | |||
| NCT02001987 TOSCA | Arthritis, Rheumatoid | Change From Baseline in Disease Activity Score Based on 28-joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24 Baseline, Week 24 | TCZ - All Participants - Core Study Period | -3.07 units on a scale (±1.52 Standard Deviation) |
| TCZ - All Participants - Core Study Period | 5.80 units on a scale (±1.14 Standard Deviation) | |||
| NCT02031471 | Arthritis, Rheumatoid | Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Full Analysis Set (FAS) From baseline to Week 24 | Tocilizumab | -3.24 Units on a scale (±1.47 Standard Deviation) |
| Tocilizumab | 5.55 Units on a scale (±1.17 Standard Deviation) | |||
| NCT02031471 | Arthritis, Rheumatoid | Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Per Protocol Set (PPS) From baseline to Week 24 | Tocilizumab | 5.73 Units on a scale (±1.33 Standard Deviation) |
| Tocilizumab | -3.21 Units on a scale (±1.42 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Early Withdrawal Baseline, early withdrawal (up to Week 52) | Tocilizumab in Combination With Methotrexate or Other DMARDs | -1.63 units on a scale (±1.480 Standard Deviation) |
| Tocilizumab Monotherapy | -2.88 units on a scale (±1.236 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 12 Baseline, Week 12 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -2.99 units on a scale (±1.510 Standard Deviation) |
| Tocilizumab Monotherapy | -2.33 units on a scale (±1.522 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 16 Baseline, Week 16 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -3.07 units on a scale (±1.532 Standard Deviation) |
| Tocilizumab Monotherapy | -2.93 units on a scale (±1.218 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 20 Baseline, Week 20 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -3.13 units on a scale (±1.525 Standard Deviation) |
| Tocilizumab Monotherapy | -3.17 units on a scale (±1.346 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 24 Baseline, Week 24 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -3.33 units on a scale (±1.470 Standard Deviation) |
| Tocilizumab Monotherapy | -3.28 units on a scale (±1.379 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 28 Baseline, Week 28 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -3.32 units on a scale (±1.552 Standard Deviation) |
| Tocilizumab Monotherapy | -3.54 units on a scale (±1.260 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 32 Baseline, Week 32 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -3.54 units on a scale (±1.448 Standard Deviation) |
| Tocilizumab Monotherapy | -3.19 units on a scale (±1.418 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 36 Baseline, Week 36 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -3.55 units on a scale (±1.589 Standard Deviation) |
| Tocilizumab Monotherapy | -3.57 units on a scale (±1.358 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 4 Baseline, Week 4 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -2.11 units on a scale (±1.215 Standard Deviation) |
| Tocilizumab Monotherapy | -1.86 units on a scale (±1.016 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 40 Baseline, Week 40 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -3.64 units on a scale (±1.524 Standard Deviation) |
| Tocilizumab Monotherapy | -3.82 units on a scale (±1.143 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 44 Baseline, Week 44 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -3.65 units on a scale (±1.574 Standard Deviation) |
| Tocilizumab Monotherapy | -3.61 units on a scale (±1.325 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 48 Baseline, Week 48 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -3.65 units on a scale (±1.552 Standard Deviation) |
| Tocilizumab Monotherapy | -3.54 units on a scale (±1.146 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 52 Baseline, Week 52 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -3.67 units on a scale (±1.592 Standard Deviation) |
| Tocilizumab Monotherapy | -3.75 units on a scale (±1.361 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in DAS28-ESR at Week 8 Baseline, Week 8 | Tocilizumab in Combination With Methotrexate or Other DMARDs | -2.62 units on a scale (±1.482 Standard Deviation) |
| Tocilizumab Monotherapy | -2.42 units on a scale (±1.352 Standard Deviation) | |||
| NCT02046603 ACT-MOVE | Arthritis, Rheumatoid | Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 2 Baseline, Week 2 | Tocilizumab in Combination With Methotrexate or Other DMARDs | 5.53 units on a scale (±1.257 Standard Deviation) |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | -1.22 units on a scale (±1.131 Standard Deviation) | |||
| Tocilizumab Monotherapy | 5.52 units on a scale (±1.014 Standard Deviation) | |||
| Tocilizumab Monotherapy | -1.41 units on a scale (±0.994 Standard Deviation) | |||
| NCT02046616 | Arthritis, Rheumatoid | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12 Baseline, Week 12 | Tocilizumab Alone or Combined With Methotrexate or Other DMARD | 24.9 units on a scale (±10.5 Standard Deviation) |
| Tocilizumab Alone or Combined With Methotrexate or Other DMARD | -16.6 units on a scale (±12.1 Standard Deviation) | |||
| NCT02453256 focuSSced | Scleroderma, Systemic | Change in Modified Rodnan Skin Score (mRSS) During Double-blind Period From baseline to week 48 | Double-Blind Placebo | -4.41 Units on a scale |
| Double-Blind Tocilizumab | -6.14 Units on a scale | |||
| NCT04320615 COVACTA | — | Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4) Day 28 | Placebo Modified Intent-to-Treat (mITT) Arm | 2.8 Percentage of Participants |
| Placebo Modified Intent-to-Treat (mITT) Arm | 5.6 Percentage of Participants | |||
| Placebo Modified Intent-to-Treat (mITT) Arm | 49.3 Percentage of Participants | |||
| Placebo Modified Intent-to-Treat (mITT) Arm | 6.9 Percentage of Participants | |||
| Placebo Modified Intent-to-Treat (mITT) Arm | 9.7 Percentage of Participants | |||
| Placebo Modified Intent-to-Treat (mITT) Arm | 6.3 Percentage of Participants | |||
| Placebo Modified Intent-to-Treat (mITT) Arm | 19.4 Percentage of Participants | |||
| Tocilizumab (TCZ) mITT Arm | 19.7 Percentage of Participants | |||
| Tocilizumab (TCZ) mITT Arm | 6.1 Percentage of Participants | |||
| Tocilizumab (TCZ) mITT Arm | 8.8 Percentage of Participants | |||
| Tocilizumab (TCZ) mITT Arm | 2.0 Percentage of Participants | |||
| Tocilizumab (TCZ) mITT Arm | 56.5 Percentage of Participants | |||
| Tocilizumab (TCZ) mITT Arm | 2.0 Percentage of Participants | |||
| Tocilizumab (TCZ) mITT Arm | 4.8 Percentage of Participants | |||
| NCT04330638 COV-AID | COVID-19 | Time to Clinical Improvement at day 15 | IL-6 Blockade | 11 days |
| IL 1 Blockade | 12 days | |||
| No IL-1 Blockade | 12 days | |||
| No IL-6 Blockade | 12 days | |||
| NCT04356937 | — | Mechanical Ventilation or Death 28 days | Placebo | 12.5 percentage of patients with event |
| Placebo | 10.0 percentage of patients with event | |||
| Tocilizumab | 10.6 percentage of patients with event | |||
| Tocilizumab | 9.9 percentage of patients with event | |||
| NCT04372186 EMPACTA | — | Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28 Up to Day 28 | Placebo | 19.26 Percentage of Participants |
| Tocilizumab | 12.04 Percentage of Participants | |||
| NCT04409262 REMDACTA | — | Time to Hospital Discharge or "Ready for Discharge" up to Day 28 Up to Day 28 | Remdesivir + Placebo (RDV+Placebo) - mITT Population | 14.0 days |
| Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population | 14.0 days | |||
| NCT05171647 SUNMO | Lymphoma, Non-Hodgkin | Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP) Up to approximately 23.8 months | Arm A: Mosun-Pola | 69.7 percentage of participants |
| Arm B: R-GemOx | 44.1 percentage of participants | |||
| NCT05171647 SUNMO | Lymphoma, Non-Hodgkin | Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans Up to 32 months | Arm A: Mosun-Pola | 11.5 months |
| Arm B: R-GemOx | 3.8 months |