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

NCT00539838 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-09-17

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Jorn Drappa, M.D., Ph.D. · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-19
Primary Completion
2011-07-12
Completion
2011-07-12

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Drugs
Diseases

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 NCT00539838 on ClinicalTrials.gov