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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00074438
First received: December 12, 2003
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: methotrexate
Drug: rituximab
Drug: corticosteroids
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Proportion of patients with an ACR20 response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with ACR(50,70) responses [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 465
Study Start Date: June 2003
Study Completion Date: July 2011
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00074438     History of Changes
Other Study ID Numbers: WA17043/U2644g, WA17043
Study First Received: December 12, 2003
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Rituxan
RA

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

ClinicalTrials.gov processed this record on April 17, 2014