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 (NCT00264550) enrolled 444 people with rheumatoid arthritis across four groups. Participants received either a placebo plus methotrexate (133 people), golimumab 100 mg plus a placebo (133 people), golimumab 50 mg plus methotrexate (89 people), or golimumab 100 mg plus methotrexate (89 people). The trial was measuring things like joint swelling and tenderness, participants' ability to perform everyday tasks, and signs of joint damage over a period of up to 24 weeks. The reported data shows that at week 14, the number of participants who met a standard measure of joint improvement (called an "ACR 20 response" — meaning at least a 20% improvement in swollen and tender joint counts alongside improvements in several other measures) was: 44 out of 133 in the placebo plus methotrexate group, 59 out of 133 in the golimumab 100 mg plus placebo group, 49 out of 89 in the golimumab 50 mg plus methotrexate group, and 50 out of 89 in the golimumab 100 mg plus methotrexate group. For everyday physical function (scored on a scale from 0 to 3, where 0 means no difficulty), the reported average improvement from the starting point at week 24 was 0.125 points in both the placebo plus methotrexate and golimumab 100 mg plus placebo groups, 0.375 points in the golimumab 50 mg plus methotrexate group, and 0.500 points in the golimumab 100 mg plus methotrexate group. For the measure of joint damage on X-ray at week 24, all four groups reported a change of 0.00 on that scale, meaning no change from the starting point was recorded in any group. The reported data also shows that at week 24, the number of participants meeting the ACR 20 response threshold was 37 in the placebo plus methotrexate group, 47 in the golimumab 100 mg plus placebo group, and 53 each in both golimumab plus methotrexate groups. A separate disease activity score (called DAS 28, a combined measure of joint counts, a blood marker, and the participant's own rating) showed a response in 67 of 133 participants in the placebo plus methotrexate group, 84 of 133 in the golimumab 100 mg plus placebo group, 64 of 89 in the golimumab 50 mg plus methotrexate group, and 67 of 89 in the golimumab 100 mg plus methotrexate group at week 14. 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 30412238) ↗
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 the screening visit
- You have been taking methotrexate (a common RA medication) at a dose of at least 15 mg per week for at least 3 months, and your dose has stayed the same for at least 4 weeks before screening
- Your RA is currently active, meaning you have at least 4 swollen and 4 tender joints, plus at least 2 of the following: certain blood test results showing inflammation, morning stiffness lasting 30 minutes or more, joint damage seen on X-ray or MRI, or specific antibodies found in your blood (confirm with trial site)
- If you take steroid tablets (like prednisone), you have been on a low, stable dose (no more than 10 mg per day) for at least 2 weeks before starting the trial
- You meet certain screening requirements related to tuberculosis (TB) (confirm with trial site)
Who may not be able to join:
- You have other inflammatory diseases besides RA that could affect how results are measured
- You have taken other immune-suppressing or disease-modifying medications (apart from methotrexate) in the 4 weeks before starting the trial
- You have previously been treated with biologic TNF-blocking medications such as infliximab, etanercept, or adalimumab
- You have a history of, or currently have, a long-term or recurring infection
- You have had a serious infection in the 2 months before starting the trial
- You have a history of certain infections such as tuberculosis (TB), histoplasmosis, or coccidioidomycosis, whether past or present
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
3 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) 20 Response at Week 14; Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.