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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147966
• Other study ID #: 041569
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: March 22, 2010
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2008
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• rituximab
treatment with rituximab

Locations

Country	Name	City	State
United States	UCSD CIT	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2007 Jul 20. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	0 and 12 weeks	No