NCT00626197

A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (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, 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.

Conditions

• Lupus Nephritis
• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Corticosteroids	Intravenous and oral repeating dose
DRUG	Cyclophosphamide	Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine.
DRUG	Mycophenolate Mofetil	Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day.
DRUG	Ocrelizumab	Ocrelizumab was administed at a dose and as per schedule in arm description
DRUG	Placebo	Placebo was administered as per schedule in arm description
DRUG	Azathioprine	Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.

Timeline

• Start date: 2008-02-15
• Primary completion: 2009-10-19
• Completion: 2013-10-28
• First posted: 2008-02-29
• Last updated: 2020-12-22
• Results posted: 2020-12-22