drugset / Trial / NCT00808210
A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab
NaParallel-groupDouble-blindTreatment
Summary
This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.
Timeline
- Start
- 2009-03-05
- Primary completion
- 2012-11-14
- Completion
- 2012-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Infliximab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Ocrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Methotrexate | Small molecule | 7.5 mg | Oral |
| Background | Methotrexate | Small molecule | 25 mg | Oral |
| Background | Methylprednisolone | Other / unclassified | — | Intravenous |