A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: March 2, 2007
Last updated: September 9, 2013
Last verified: September 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||A Long-Term Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with RA who have had an inadequate response to one or more anti-TNF therapies
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443443
||Swati Tole, M.D., M.S.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 2, 2007
||September 9, 2013
||United States: Food and Drug Administration
Keywords provided by Genentech:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Connective Tissue Diseases
Immune System Diseases