drugset / Trial / NCT02720120
A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is in two parts and will evaluate the safety, tolerability and efficacy of escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation study, at one of the following dose levels of ocrelizumab \[400, 1000, 1500, and 2000 milligrams (mg)\]. In Part 2, participants will be randomized to explore tolerability and efficacy of doses which have been shown to be tolerated in Part 1.
Timeline
- Start
- 2005-10
- Primary completion
- 2013-02
- Completion
- 2013-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocrelizumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | Ocrelizumab | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | Ocrelizumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Ocrelizumab | Monoclonal antibody | 2000 mg | Intravenous |