Status:
COMPLETED
A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Biogen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational study designed to follow patients with RA who have had an inadequate response to one or more anti-TNF therapies and who will receive Rituxan. Approximately 1000 patients in th...
Eligibility Criteria
Inclusion
- No prior use of Rituxan (except if received within 8 weeks of screening)
- Signed Informed Consent Form
- Age ≥ 18 years
- Diagnosis of RA
- Inadequate response to one or more anti-TNF therapies
Exclusion
- Have known hypersensitivity to any component of a humanized or murine monoclonal antibody
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
1026 Patients enrolled
Trial Details
Trial ID
NCT00443443
Start Date
January 1 2007
End Date
September 1 2013
Last Update
March 30 2015
Active Locations (193)
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1
Rheumatology Associates, PC
Birmingham, Alabama, United States, 35205
2
Rheumatology Associates of N. AL, P.C.
Huntsville, Alabama, United States, 35801
3
Clinic for Rheumatic Diseases - Research Department
Tuscaloosa, Alabama, United States, 35406
4
Arizona Arthritis and Rheumatology Research, PLLC
Paradise Valley, Arizona, United States, 85253