A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00443443
- Lead Sponsor
- Genentech, Inc.
- 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 the United States with RA who have had an inadequate response to anti-TNF therapies and who will receive Rituxan therapy will be recruited. There is no protocol mandated treatment assignment in this study. Patients will be evaluated and treated according to their physician's standard practice and discretion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1026
- 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
- Have known hypersensitivity to any component of a humanized or murine monoclonal antibody
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (165)
Rheumatology Associates, PC
🇺🇸Birmingham, Alabama, United States
Rheumatology Associates of N. AL, P.C.
🇺🇸Huntsville, Alabama, United States
Clinic for Rheumatic Diseases - Research Department
🇺🇸Tuscaloosa, Alabama, United States
Arizona Arthritis and Rheumatology Research, PLLC
🇺🇸Paradise Valley, Arizona, United States
Phoenix Rheumatology Specialists, Ltd.
🇺🇸Phoenix, Arizona, United States
Advanced Arthritis Care & Research
🇺🇸Scottsdale, Arizona, United States
The Arthritis Center of the Ozarks
🇺🇸Fayetteville, Arkansas, United States
Investigational Site
🇺🇸Tacoma, Washington, United States
Arthritis Medical Clinic of North County, Inc.
🇺🇸Escondido, California, United States
Solano Regional Medical Group
🇺🇸Fairfield, California, United States
Scroll for more (155 remaining)Rheumatology Associates, PC🇺🇸Birmingham, Alabama, United States