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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)

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: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Phase
Rheumatoid Arthritis
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long-Term Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Genentech:

Enrollment: 1026
Study Start Date: January 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with RA who have had an inadequate response to one or more anti-TNF therapies

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443443

  Show 193 Study Locations
Sponsors and Collaborators
Genentech
Biogen Idec
Investigators
Study Director: Swati Tole, M.D., M.S. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00443443     History of Changes
Other Study ID Numbers: U3839g, BIIB
Study First Received: March 2, 2007
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Rituximab
RA
Sunstone
anti-TNF
Rituxan

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 17, 2013