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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)

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ClinicalTrials.gov Identifier: NCT00443443
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : March 30, 2015
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
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.

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 1026 participants
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)
Study Start Date : January 2007
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443443


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

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00443443     History of Changes
Other Study ID Numbers: U3839g
BIIB
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Keywords provided by Genentech, Inc.:
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
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents