Phase 3
Completed N=643
A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Source: ClinicalTrials.gov NCT00361335 ↗Enrolled (actual)
643
Serious AEs
10.4%
Results posted
Aug 2012
Primary outcomePrimary: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 — 28; 16; 27; 25 Participants — p=0.051
Summary
The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 |
28; 16; 27; 25; 17; 55 | 0.051 |
| SECONDARY Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24 |
24; 11; 32; 15; 12; 56 | 0.002 sig |
| SECONDARY Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 |
71; 51; 66; 62; 36; 137 | <0.001 sig |
| SECONDARY Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14 |
89; 80; 94; 83; 57; 183 | <0.001 sig |
| SECONDARY Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14 |
6.92; 4.03; 6.76; 5.14; 4.27; 6.84 | 0.005 sig |
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender joints for at least 3 months prior to screening - Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
Exclusion Criteria
- Participants having known hypersensitivity (severe allergy) to human immunoglobulin proteins or other components of golimumab - Having known clinically serious adverse reaction to a biologic anti-TNF agent - Have had history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening
Data sourced from ClinicalTrials.gov (NCT00361335). 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.