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

May 7, 2013 updated by: Genentech, Inc.

Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

465

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Eligibility criteria include, but are not limited to the following:

  • Are between the ages of 18 and 80 years.
  • Have been diagnosed with rheumatoid arthritis for at least 6 months.
  • Have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: rituximab
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Experimental: 2
Drug: rituximab
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: corticosteroids
Intravenous repeating dose
Experimental: 3
Drug: rituximab
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: corticosteroids
Intravenous repeating dose
Experimental: 4
Drug: rituximab
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Experimental: 5
Drug: rituximab
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: corticosteroids
Intravenous repeating dose
Experimental: 6
Drug: rituximab
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: corticosteroids
Intravenous repeating dose
Placebo Comparator: 9
Drug: placebo
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: corticosteroids
Intravenous repeating dose
Placebo Comparator: 8
Drug: placebo
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: corticosteroids
Intravenous repeating dose
Placebo Comparator: 7
Drug: placebo
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with an ACR20 response
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with ACR(50,70) responses
Time Frame: 24 weeks
24 weeks
Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Collaborators

Roche Pharma AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 12, 2003

First Submitted That Met QC Criteria

December 12, 2003

First Posted (Estimate)

December 15, 2003

Study Record Updates

Last Update Posted (Estimate)

May 9, 2013

Last Update Submitted That Met QC Criteria

May 7, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WA17043/U2644g
  • WA17043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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