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 |
|---|---|---|---|---|
| NCT00264537 | Arthritis, Rheumatoid | Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 Baseline and Week 52 | Combined Golimumab + Methotrexate | 0.41 Scores on a scale (±3.929 Standard Deviation) |
| Group 1: Placebo + Methotrexate | 1.37 Scores on a scale (±4.555 Standard Deviation) | |||
| Group 2: Golimumab 100 mg + Placebo | 1.25 Scores on a scale (±6.155 Standard Deviation) | |||
| Group 3: Golimumab 50 mg + Methotrexate | 0.74 Scores on a scale (±5.233 Standard Deviation) | |||
| Group 4: Golimumab 100 mg + Methotrexate | 0.07 Scores on a scale (±1.833 Standard Deviation) | |||
| NCT00264537 | Arthritis, Rheumatoid | Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 Week 24 | Combined Golimumab + Methotrexate | 122 Participants |
| Group 1: Placebo + Methotrexate | 47 Participants | |||
| Group 2: Golimumab 100 mg + Placebo | 52 Participants | |||
| Group 3: Golimumab 50 mg + Methotrexate | 64 Participants | |||
| Group 4: Golimumab 100 mg + Methotrexate | 58 Participants | |||
| NCT00264550 GO-FORWARD | Arthritis, Rheumatoid | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24 Baseline (Week 0) and Week 24 | Combined Golimumab + Methotrexate | 0.4375 Units on a scale |
| Group 1: Placebo + Methotrexate | 0.1250 Units on a scale | |||
| Group 2: Golimumab 100 mg + Placebo | 0.1250 Units on a scale | |||
| Group 3: Golimumab 50 mg + Methotrexate | 0.3750 Units on a scale | |||
| Group 4: Golimumab 100 mg + Methotrexate | 0.5000 Units on a scale | |||
| NCT00264550 GO-FORWARD | Arthritis, Rheumatoid | Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 Week 14 | Combined Golimumab + Methotrexate | 99 Participants |
| Group 1: Placebo + Methotrexate | 44 Participants | |||
| Group 2: Golimumab 100 mg + Placebo | 59 Participants | |||
| Group 3: Golimumab 50 mg + Methotrexate | 49 Participants | |||
| Group 4: Golimumab 100 mg + Methotrexate | 50 Participants | |||
| NCT00265083 | Spondylitis, Ankylosing | Assessment in Ankylosing Spondylitis 20 Responders at Week 14 Week 14 | Combined: Groups II & III | 166 Participants |
| Group I: Placebo | 17 Participants | |||
| Group II: Golimumab 50 mg | 82 Participants | |||
| Group III: Golimumab 100 mg | 84 Participants | |||
| NCT00265096 GO-REVEAL | Arthritis, Psoriatic | American College of Rheumatology (ACR) 20 Response at Week 14 Baseline (Week 0), Week 4, Week 8 and Week 14 | Combined: Group II & III | 140 Participants |
| Group I: Placebo | 10 Participants | |||
| Group II: Golimumab 50 mg | 74 Participants | |||
| Group III: Golimumab 100 mg | 66 Participants | |||
| NCT00265096 GO-REVEAL | Arthritis, Psoriatic | Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24 Baseline and Week 24 | Combined: Group II & III | -0.09 Scores on a scale (±1.315 Standard Deviation) |
| Group I: Placebo | 0.27 Scores on a scale (±1.259 Standard Deviation) | |||
| Group II: Golimumab 50 mg | -0.16 Scores on a scale (±1.309 Standard Deviation) | |||
| Group III: Golimumab 100 mg | -0.02 Scores on a scale (±1.322 Standard Deviation) | |||
| NCT00299546 | Arthritis, Rheumatoid | American College of Rheumatology (ACR) 20 Response at Week 14. Week 14 | Combined Golimumab | 105 participants |
| Group 1: Placebo | 27 participants | |||
| Group 2: Golimumab 50 mg | 51 participants | |||
| Group 3: Golimumab 100 mg | 54 participants | |||
| NCT00361335 | Arthritis, Rheumatoid | Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 Week 0 to Week 14 | Group I: 2mg/kg Golimumab+ MTX | 28 Participants |
| Group II: 2mg/kg Golimumab Only | 16 Participants | |||
| Group III: 4mg/kg Golimumab + MTX | 27 Participants | |||
| Group IV: 4mg/kg Golimumab Only | 25 Participants | |||
| Group V: IV Placebo + MTX | 17 Participants | |||
| Group VI: Combined Groups I and III | 55 Participants | |||
| Group VII: Combined Groups II and IV | 41 Participants | |||
| NCT00487539 | Colitis, Ulcerative | Number of Participants With Clinical Response at Week 6 Baseline, Week 6 | Golimumab 200 mg -> 100 mg | 129 Participants |
| Golimumab 400 mg -> 200 mg | 141 Participants | |||
| Placebo | 76 Participants | |||
| NCT00488631 | Colitis, Ulcerative | Number of Participants in Clinical Response Through Week 54 Induction Baseline, Week 0 through Week 54 | GLM-I-Rsp-Golimumab 100 mg Maintenance | 75 Participants |
| GLM-I-Rsp-Golimumab 50 mg Maintenance | 71 Participants | |||
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | 48 Participants | |||
| NCT00488774 | Colitis, Ulcerative | Number of Participants With Clinical Response Week 6 | Golimumab 1 mg Per kg | 22 Participants |
| Golimumab 2 mg Per kg | 33 Participants | |||
| Golimumab 4 mg Per kg | 32 Participants | |||
| Placebo | 22 Participants | |||
| NCT00973479 | Arthritis, Rheumatoid | Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 Week 14 | Group I: Placebo + Methotrexate (MTX) | 24.9 Percentage of Participants |
| Group II: Golimumab 2 mg/kg + Methotrexate (MTX) | 58.5 Percentage of Participants | |||
| NCT00975130 GO-MORE | Arthritis, Rheumatoid | Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6 Month 6 | GLM50-SC | 2692 Participants |
| NCT00975130 GO-MORE | Arthritis, Rheumatoid | Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 Start of Month 11, End of Month 12 | IV-GLM2/SC-GLM50 | 58 Participants |
| IV-GLM2/SC-GLM50 | 59 Participants | |||
| SC-GLM50 | 67 Participants | |||
| SC-GLM50 | 64 Participants | |||
| NCT01004432 | Arthritis, Rheumatoid | Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14 Week 14 | OL Overall Group: Golimumab 50 mg SC + MTX | 34.9 percentage of participants |
| NCT01230827 | Arthritis, Juvenile | Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48 Week 16 through Week 48 | CNTO 148 (Golimumab) | 59.0 Percentage of Participants |
| Placebo | 52.6 Percentage of Participants | |||
| NCT01248780 | Arthritis, Rheumatoid | American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14 Week 14 | Group I: Placebo + MTX | 21 Number of participants |
| Group II: Golimumab 50 mg + MTX | 54 Number of participants | |||
| NCT01248793 | Spondylitis, Ankylosing | Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14 Week 14 | Group I: Placebo | 26 Participants |
| Group II: Golimumab 50 mg | 53 Participants | |||
| NCT01453725 GO-AHEAD | Spondylitis, Ankylosing | Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16 Week 16 | Golimumab→Golimumab | 71.1 Percentage of Participants |
| Placebo→Golimumab | 40.0 Percentage of Participants | |||
| NCT01453725 GO-AHEAD | Spondylitis, Ankylosing | Percentage of Participants Who Discontinued Study Drug Due to an AE Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2 | Golimumab→Golimumab | 2.1 Percentage of Participants |
| Golimumab→Golimumab | 1.1 Percentage of Participants | |||
| Placebo→Golimumab | 1.0 Percentage of Participants | |||
| Placebo→Golimumab | 2.1 Percentage of Participants | |||
| NCT01453725 GO-AHEAD | Spondylitis, Ankylosing | Percentage of Participants Who Experienced at Least One Adverse Event (AE) Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug) | Golimumab→Golimumab | 41.9 Percentage of Participants |
| Golimumab→Golimumab | 41.2 Percentage of Participants | |||
| Placebo→Golimumab | 47.0 Percentage of Participants | |||
| Placebo→Golimumab | 54.2 Percentage of Participants | |||
| NCT01863771 | Colitis, Ulcerative | Number of Participants Who Achieved Clinical Response Through Maintenance-Week 54 Measured Using the Mayo Score Up to Week 54 | Golimumab | 18 participants |
| Placebo | 6 participants | |||
| NCT02065713 GO-DACT | Arthritis, Psoriatic | Dactylitis Severity Score (DSS) From baseline to week 24 | Golimumab in Combination With Methotrexate | -5 change of score on a scale |
| Placebo in Combination With Methotrexate | -2 change of score on a scale | |||
| NCT02181673 | Arthritis, Psoriatic | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14 Week 14 | Golimumab | 75.1 Percentage of Participants |
| Placebo | 21.8 Percentage of Participants | |||
| NCT02186873 | Spondylitis, Ankylosing | Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16 Week 16 | Group 1: Placebo Then Golimumab | 26.2 Percentage of Participants |
| Group 2: Golimumab | 73.3 Percentage of Participants | |||
| NCT02277444 GO-VIVA | Arthritis, Juvenile | Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28 Week 28 | Golimumab | 399 micrograms*day/milliliter (mcg*day/mL) |
| NCT02277444 GO-VIVA | Arthritis, Juvenile | Serum Trough Concentration (C-trough) of Golimumab Week 28 | Golimumab | 0.50 micrograms per milliliter (mcg/mL) (±0.427 Standard Deviation) |
| NCT02437162 | Axial Spondyloarthritis | Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24 Week 24 | Placebo | 28.4 Percentage of participants |
| Ustekinumab 45 Milligram (mg) | 31.0 Percentage of participants | |||
| Ustekinumab 90 mg | 28.1 Percentage of participants | |||
| NCT02438787 | Spondylitis, Ankylosing | Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 Week(W) 24 | Placebo | 12.3 Percentage of participants |
| Ustekinumab 45mg | 19.2 Percentage of participants | |||
| Ustekinumab 90mg | 26.9 Percentage of participants | |||
| NCT03270501 GO-GUT | Axial Spondyloarthritis | Proportion of Patients Achieving Sustained Clinical Remission Upon end of trial for individual patient, between 28 and 52 weeks. | Arm 1: NSAIDs With Possible Step-up to Golimumab | 34 Participants |
| NCT03596645 PURSUIT 2 | Colitis, Ulcerative | Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Mayo Score Week 6 | Group 1: Golimumab | 31.9 Percentage of participants |
| NCT04108468 GOLMePsA | Arthritis, Psoriatic | Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks 24 weeks | Golimumab & Methotrexate | 2.70 score on a scale (±1.38 Standard Deviation) |
| Methotrexate | 3.09 score on a scale (±1.32 Standard Deviation) |