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

PHASE3TerminatedINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

February 15, 2008

Primary Completion Date

October 19, 2009

Study Completion Date

October 28, 2013

Conditions
Lupus NephritisSystemic Lupus Erythematosus
Interventions
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.

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Genentech, Inc.

INDUSTRY

NCT00626197 - A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG) | Biotech Hunter | Biotech Hunter