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OpenTrials
Completed

NCT Number: NCT00074438

Study to Assess the Efficacy and Safety of Rituximab in Patients With 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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

methotrexate

Drug

Oral or parenteral repeating dose

Rituximab

Drug

Intravenous repeating dose

Corticosteroids

Drug

Intravenous repeating dose

Placebo

Drug

Intravenous repeating dose

Primary outcomes

  1. Proportion of patients with an ACR20 response

    Time frame: 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Collaborators

  • Roche Pharma AG

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2011
First posted
Dec 15, 2003
Registry last updated
May 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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