drugset / Trial / NCT00539838
A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background immunosuppressive medication and a corticosteroid regimen in patients with moderately to severely active systemic lupus erythematosus, who do not have moderate to severe glomerulonephritis.
Timeline
- Start
- 2007-12-19
- Primary completion
- 2011-07-12
- Completion
- 2011-07-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocrelizumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | Ocrelizumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Azathioprine | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | — |
| Background | Methylprednisolone | Other / unclassified | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Prednisone | Other / unclassified | — | — |