Back to resultsAssessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rituximab
Sponsored by
About this trial
This is an interventional diagnostic trial for Rheumatoid Arthritis focused on measuring active disease despite concomitant methotrexate
Eligibility 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
Sites / Locations
- UCSD CIT
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ritxumab
Arm Description
all patients get treatment
Outcomes
Primary Outcome Measures
American College of Rheumatology (ACR) 20 at Week 12
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00147966
First Posted
September 2, 2005
Last Updated
March 22, 2010
Sponsor
University of California, San Diego
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00147966
Brief Title
Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)
Official Title
Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial Biopsies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Diego
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
active disease despite concomitant methotrexate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ritxumab
Arm Type
Experimental
Arm Description
all patients get treatment
Intervention Type
Drug
Intervention Name(s)
rituximab
Other Intervention Name(s)
rituxan
Intervention Description
treatment with rituximab
Primary Outcome Measure Information:
Title
American College of Rheumatology (ACR) 20 at Week 12
Description
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).
Time Frame
0 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Kavanaugh, MD
Organizational Affiliation
UCSD CIT
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD CIT
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17644541
Citation
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.
Results Reference
background
PubMed Identifier
18761748
Citation
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.
Results Reference
background
PubMed Identifier
21098574
Citation
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.
Results Reference
derived
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Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)
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