drugset / Trial / NCT00539838

A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)

NCT00539838 ↗

Phase 3 Terminated 33 enrolled Genentech, Inc. Roche Pharma AG · collab
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

Outcome

Outcome not reported

Stopped: “The study was terminated prematurely when the decision was made that ocrelizumab was not likely to benefit this patient population.”

Drugs

EvaluationDrugModalityDoseRoute
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 — —