Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 637 people with rheumatoid arthritis, divided into four groups of approximately 159–160 people each. The groups were: a placebo injection plus the existing medicine methotrexate; the drug golimumab at 100 mg plus a placebo (no methotrexate); golimumab at 50 mg plus methotrexate; and golimumab at 100 mg plus methotrexate. The trial was measuring two main things: how many participants showed a meaningful improvement in joint swelling, pain, and physical function scores at 24 weeks, and how much joint damage (as seen on imaging) had changed after 52 weeks. Not everyone finished the study — between 99 and 110 people in each group completed it. The reported data shows that for the main 24-week measure (called an ACR 50 response — meaning at least a 50% improvement across several joint and symptom scores), the numbers of participants who reached that point were: 47 out of 160 in the placebo-plus-methotrexate group, 52 out of 159 in the golimumab 100 mg-plus-placebo group, 64 out of 159 in the golimumab 50 mg-plus-methotrexate group, and 58 out of 159 in the golimumab 100 mg-plus-methotrexate group. For a less stringent improvement threshold (ACR 20, meaning at least 20% improvement), the reported numbers were 79, 82, 98, and 98 participants respectively across those same four groups. For the second main measure — change in a joint-damage score (on a scale of 0 to 448, where higher means more damage) after 52 weeks — the reported average changes from the starting point were: +1.37 in the placebo-plus-methotrexate group, +1.25 in the golimumab 100 mg-plus-placebo group, +0.74 in the golimumab 50 mg-plus-methotrexate group, and +0.07 in the golimumab 100 mg-plus-methotrexate group. The reported data also includes a subgroup of participants who had an elevated inflammation marker (C-reactive protein) at the start of the trial. In that subgroup, the joint-damage score changes reported were +2.16 (placebo plus methotrexate), +2.19 (golimumab 100 mg plus placebo), +1.29 (golimumab 50 mg plus methotrexate), and +0.16 (golimumab 100 mg plus methotrexate). These are simply the numbers that were recorded and reported — no interpretation of what they mean for any individual should be drawn from them alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 27803138) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Rheumatoid Arthritis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with rheumatoid arthritis (RA) for at least 3 months before starting the study
- You have never taken methotrexate (MTX) before, or have taken no more than 3 weekly doses of it for RA at any time
- Your RA is currently active, meaning you have at least 4 swollen and 4 tender joints, plus at least 2 of the following: elevated inflammation markers in a blood test, morning stiffness lasting 30 minutes or more, joint damage seen on X-ray or MRI, or a positive blood test for certain RA-related antibodies (confirm with trial site)
- If you are taking steroid tablets (such as prednisone), you must have been on a low, stable dose of no more than 10mg per day for at least 2 weeks before starting the study
Who may not be able to join:
- You have another inflammatory disease (besides RA) that could affect how the study results are measured
- You have taken certain RA medications known as DMARDs or immune-suppressing drugs in the 4 weeks before starting the study
- You have previously been treated with biologic anti-TNF medications such as infliximab, etanercept, or adalimumab
- You have a history of, or currently have, a long-term or repeatedly occurring infectious disease
- You have had a serious infection within 2 months before starting the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Centocor, Inc. Clinical Trial, Centocor, Inc.
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24; Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.