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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00443443

Acronym

SUNSTONE

Enrollment

1026

Registered

2007-03-06

Start date

2007-01-31

Completion date

2013-09-30

Last updated

2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rituximab, RA, Sunstone, anti-TNF, Rituxan

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

Puerto Rico, United States

Outcome results