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Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

NCT00074438 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2013-05-09

No results posted yet for this study

Summary

This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).

Conditions

Interventions

DRUG

methotrexate

Oral or parenteral repeating dose

DRUG

rituximab

Intravenous repeating dose

DRUG

corticosteroids

Intravenous repeating dose

DRUG

placebo

Intravenous repeating dose

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Genentech, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2004-09-30
Completion
2011-07-31

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Entities

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 NCT00074438 on ClinicalTrials.gov