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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.
  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:


Further study details as provided by Genentech, Inc.:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00443443     History of Changes
Other Study ID Numbers: U3839g
BIIB
First Submitted: March 2, 2007
First Posted: March 6, 2007
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


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