Phase 3
Completed N=444
An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Source: ClinicalTrials.gov NCT00264550 ↗Enrolled (actual)
444
Serious AEs
39.6%
Results posted
Mar 2014
Primary outcomePrimary: Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 — 44; 59; 49; 50 Participants — p=<0.001
Summary
The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 |
44; 59; 49; 50; 99 | <0.001 sig |
| PRIMARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24 |
0.1250; 0.1250; 0.3750; 0.5000; 0.4375 | <0.001 sig |
| SECONDARY Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14 |
67; 84; 64; 67; 131 | <0.001 sig |
| SECONDARY Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24 |
37; 47; 53; 53; 106 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14 |
0.1250; 0.2500; 0.3750; 0.3750; 0.3750 | <0.001 sig |
| SECONDARY Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24 |
0.00; 0.00; 0.00; 0.00; 0.00 | 0.551 |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to screening
- Must have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a MTX dose of >=15 mg/week and =1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or magnetic resonance imaging (MRI) prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening
- If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent
- Are considered eligible according to specified tuberculosis (TB) screening criteria
Exclusion Criteria
- Have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy
- Have had treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX, during the 4 weeks prior to the first administration of study agent
- Have had prior treatment with biologic anti-tumor necrosis factor (TNF) drugs (infliximab, etanercept, adalimumab)
- Have had history of, or ongoing, chronic or recurrent infectious disease.
- Have serious infection within 2 months prior to first administration of study agent
- Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening
Data sourced from ClinicalTrials.gov (NCT00264550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.