NCT00539838

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

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Prednisone	Oral repeating dose
DRUG	Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)	Oral repeating dose
DRUG	Methylprednisolone	Intravenous repeating dose
DRUG	Ocrelizumab	Intravenous repeating dose
DRUG	Placebo	Intravenous repeating dose

Timeline

• Start date: 2007-12-19
• Primary completion: 2011-07-12
• Completion: 2011-07-12
• First posted: 2007-10-05
• Last updated: 2020-09-17
• Results posted: 2020-09-17