- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00147966
Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)
March 22, 2010 updated by: University of California, San Diego
Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial Biopsies
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92093
- UCSD CIT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ritxumab
all patients get treatment
|
treatment with rituximab
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
0 and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Arthur Kavanaugh, MD, UCSD CIT
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kavanaugh A, Rosengren S, Lee SJ, Hammaker D, Firestein GS, Kalunian K, Wei N, Boyle DL. Assessment of rituximab's immunomodulatory synovial effects (ARISE trial). 1: clinical and synovial biomarker results. Ann Rheum Dis. 2008 Mar;67(3):402-8. doi: 10.1136/ard.2007.074229. Epub 2007 Jul 20.
- Rosengren S, Wei N, Kalunian KC, Zvaifler NJ, Kavanaugh A, Boyle DL. Elevated autoantibody content in rheumatoid arthritis synovia with lymphoid aggregates and the effect of rituximab. Arthritis Res Ther. 2008;10(5):R105. doi: 10.1186/ar2497. Epub 2008 Sep 1.
- Rosengren S, Wei N, Kalunian KC, Kavanaugh A, Boyle DL. CXCL13: a novel biomarker of B-cell return following rituximab treatment and synovitis in patients with rheumatoid arthritis. Rheumatology (Oxford). 2011 Mar;50(3):603-10. doi: 10.1093/rheumatology/keq337. Epub 2010 Nov 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 2, 2005
First Submitted That Met QC Criteria
September 2, 2005
First Posted (Estimate)
September 7, 2005
Study Record Updates
Last Update Posted (Estimate)
March 23, 2010
Last Update Submitted That Met QC Criteria
March 22, 2010
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- 041569
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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