A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)
Summary
This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.
Timeline
- Start
- 2006-12-27
- Primary completion
- 2009-10-06
- Completion
- 2015-04-22
Outcome
Met primary endpoint
Stopped: “Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.”
paper With both ocrelizumab doses, the primary end point was met, and the signs and symptoms of RA were significantly improved at weeks 24 and 48. PMID 21905001 ↗
registry Placebo × 2 IV + MTX vs Ocrelizumab 200 mg × 2 IV + MTX; p < 0.0001 NCT00406419 ↗
registry Placebo × 2 IV + MTX vs Ocrelizumab 500 mg × 2 IV + MTX; p < 0.0001 NCT00406419 ↗
Publications
- Emery P, Rigby W, Tak PP, Dorner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.
- Rigby W, Tony HP, Oelke K, Combe B, Laster A, von Muhlen CA, Fisheleva E, Martin C, Travers H, Dummer W. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a forty-eight-week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum. 2012 Feb;64(2):350-9. doi: 10.1002/art.33317.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Ocrelizumab | Monoclonal antibody | 500 mg | Intravenous |
| Background | Methotrexate | Small molecule | 7.5 mg | Oral |
| Background | Methotrexate | Small molecule | 25 mg | Oral |