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

NCT00626197 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2020-12-22

Study results available
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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

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 & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-15
Primary Completion
2009-10-19
Completion
2013-10-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00626197 on ClinicalTrials.gov