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Completed

NCT Number: NCT00147966

Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)

Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCSD CIT

La Jolla, California, 92093, United States

About this study

Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur after treatment with rituximab.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Active rheumatoid arthritis
  • Use of concomitant methotrexate

Exclusion criteria

  • Use of disease-modifying anti-rheumatic drugs (DMARDs)/biologics other than methotrexate
  • Serious medical conditions that would preclude the use of the treating agent

Treatment and study plan

Rituximab

Drug

treatment with rituximab

Other names: rituxan

Primary outcomes

  1. American College of Rheumatology (ACR) 20 at Week 12

    Time frame: 0 and 12 weeks

    ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP).

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial Biopsies

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 7, 2005
Registry last updated
Mar 23, 2010

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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