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

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ClinicalTrials.gov Identifier: NCT00074438
Recruitment Status : Completed
First Posted : December 15, 2003
Last Update Posted : May 9, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: methotrexate Drug: rituximab Drug: corticosteroids Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2003
Primary Completion Date : September 2004
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients with an ACR20 response [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients with ACR(50,70) responses [ Time Frame: 24 weeks ]
  2. Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00074438     History of Changes
Other Study ID Numbers: WA17043/U2644g
WA17043
First Posted: December 15, 2003    Key Record Dates
Last Update Posted: May 9, 2013
Last Verified: May 2013

Keywords provided by Genentech, Inc.:
Rituxan
RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Methotrexate
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors