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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00147966
First received: September 2, 2005
Last updated: March 22, 2010
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: rituximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial Biopsies

Resource links provided by NLM:

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

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • American College of Rheumatology (ACR) 20 at Week 12 [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 24
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ritxumab
all patients get treatment
 Drug: rituximab
treatment with rituximab
Other Name: rituxan

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147966

Locations
United States, California
UCSD CIT
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Genentech
Investigators
Principal Investigator: Arthur Kavanaugh, MD UCSD CIT
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Arthur Kavanaugh, UCSD
ClinicalTrials.gov Identifier: NCT00147966     History of Changes
Other Study ID Numbers: 041569
Study First Received: September 2, 2005
Results First Received: March 19, 2010
Last Updated: March 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
active disease despite concomitant methotrexate

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013