A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis
Summary
The primary objectives of this study is to explore the efficacy of mavrilimumab compared with golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor (TNF) agents (excluding golimumab) for efficacy or safety reasons.
Timeline
- Start
- 2013-03
- Primary completion
- 2014-11
- Completion
- 2015-02
Outcome
Missed primary endpoint
registry p = 0.666; Percent difference -3.5 (90% CI -16.8 to 9.8) NCT01715896 ↗
registry p = 0.293; Percent difference -8.6 (90% CI -22.0 to 4.8) NCT01715896 ↗
registry p = 0.156; Percent difference -9.8 (90% CI -21.1 to 1.4) NCT01715896 ↗
registry p = 0.108; Percent difference -11.6 (90% CI -23.2 to 0.0) NCT01715896 ↗
registry p = 0.2080; Percent difference -10.3 (90% CI -23.7 to 3.0) NCT01715896 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | Mavrilimumab | Monoclonal antibody | 100 mg | Subcutaneous |