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A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE) (SUNSTONE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00443443
First Posted: March 6, 2007
Last Update Posted: March 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biogen
Information provided by (Responsible Party):
Genentech, Inc.
March 2, 2007
March 6, 2007
March 30, 2015
January 2007
September 2013   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00443443 on ClinicalTrials.gov Archive Site
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A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)
A Long-Term Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients with RA who have had an inadequate response to one or more anti-TNF therapies
Rheumatoid Arthritis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1026
September 2013
September 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • Have known hypersensitivity to any component of a humanized or murine monoclonal antibody
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00443443
U3839g
BIIB
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Genentech, Inc.
Genentech, Inc.
Biogen
Study Director: Swati Tole, M.D., M.S. Genentech, Inc.
Genentech, Inc.
March 2015