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.

Sponsors and Collaborators:	Genentech Biogen Idec
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00443443

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. No study specific visits, procedures, or treatments will be conducted; patients will be evaluated according to their physician's standard practice and discretion.

Condition	Phase
Rheumatoid Arthritis	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Rituximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	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)

Further study details as provided by Genentech:

Estimated Enrollment:	1000
Study Start Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

David Yocum, M.D.

Genentech

More Information

Study ID Numbers:	U3839g, BIIB
Study First Received:	March 2, 2007
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00443443
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Rituximab
RA
Sunstone
anti-TNF
Rituxan

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Rituximab
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009