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.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00443443
First received: March 2, 2007
Last updated: September 9, 2013
Last verified: September 2013

March 2, 2007
September 9, 2013
January 2007
December 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.
 
Active, not recruiting
1026
December 2013
December 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00443443
U3839g, BIIB
Not Provided
Genentech
Genentech
Biogen Idec
Study Director: Swati Tole, M.D., M.S. Genentech
Genentech
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP