Phase 3
Completed N=592
An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00973479 ↗
Enrolled (actual)
592
Serious AEs
18.2%
Results posted
Oct 2013
Primary outcomePrimary: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 — 24.9; 58.5 Percentage of Participants — p=<0.001
Summary
The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 |
24.9; 58.5 | <0.001 sig |
| SECONDARY Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14 |
40.1; 81.3 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14 |
0.1250; 0.5000 | <0.001 sig |
| SECONDARY Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 |
13.2; 34.9 | <0.001 sig |
| SECONDARY Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24. |
1.09; 0.03 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of rheumatoid arthritis (RA) for at least 3 months prior to screening
- 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 been on a stable MTX dose of 15 mg/week to 25 mg/week for at least 4 weeks prior to screening
- Have an active RA, as defined by disease activity with at least 6 swollen and 6 tender joints, at the time of screening and at baseline
- C-Reactive Protein greater than or equal to 1.0 mg/dL at screening
- No history of latent or active tuberculosis prior to screening
Exclusion Criteria
- Other inflammatory diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or lyme disease
- Treated with disease modifying agents (other than methotrexate)/systemic immunosuppressives (eg, D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate mofetil) during the 4 weeks prior to first administration of study agent
- Received intra-articular (in the joint), intramuscular (in the muscle), or intravenous corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to first administration of study agent
- Known allergy to human immunoglobulin proteins or other components of golimumab
- Received any commercial or investigational anti-tumor necrosis factor alpha therapy such as but not exclusively infliximab, golimumab, adalimumab or etanercept
Data sourced from ClinicalTrials.gov (NCT00973479). 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.