NCT00443443

A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT00443443

Principal Investigator:

Study Type:

OBSERVATIONAL

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)

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.

Eligibility

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

Disease(s) and\or Condition(s)

Rheumatoid Arthritis

Primary Purpose

Intervention/Treatment

Sponsor

Genentech, Inc.