drugset / Trial / NCT00626197
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a Phase III, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC (corticosteroid plus one of two immunosuppressant regimens) compared with placebo added to SOC in patients with WHO or ISN Class III or IV lupus nephritis.
Timeline
- Start
- 2008-02-15
- Primary completion
- 2009-10-19
- Completion
- 2013-10-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocrelizumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | Ocrelizumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Azathioprine | Small molecule | 2 mg/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 500 mg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 3 g | Oral |
| Background | Prednisone | Other / unclassified | — | Intravenous |