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

Completed

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00443443

Run by

Genentech, Inc.

People needed

1026

Starts

2007-01-01

Expected to finish

2013-09-01

Last updated by the study team

2015-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Have known hypersensitivity to any component of a humanized or murine monoclonal antibody

Where it is running

• Rheumatology Associates of N. AL, P.C. — Huntsville, Alabama, United States
• Clinic for Rheumatic Diseases - Research Department — Tuscaloosa, Alabama, United States
• Arizona Arthritis and Rheumatology Research, PLLC — Paradise Valley, Arizona, United States
• Phoenix Rheumatology Specialists, Ltd. — Phoenix, Arizona, United States
• Advanced Arthritis Care & Research — Scottsdale, Arizona, United States
• The Arthritis Center of the Ozarks — Fayetteville, Arkansas, United States
• Investigational Site — Covina, California, United States
• Arthritis Medical Clinic of North County, Inc. — Escondido, California, United States
• Solano Regional Medical Group — Fairfield, California, United States
• Clinical Trials of St. Jude Heritage Medical Group — Fullerton, California, United States
• Investigational Site — Hemet, California, United States
• Allergy and Rheumatology Medical Clinic, Inc — La Jolla, California, United States
• Investigational Site — La Mesa, California, United States
• Arthritis Center of Southern Orange County — Laguna Hills, California, United States
• VA Loma Linda Healthcare System — Loma Linda, California, United States
• Valerius Medical Group and Research Center of Greater Long Beach, Inc. — Long Beach, California, United States
• Beverly Medical Associates — Los Angeles, California, United States
• Investigational Site — Los Angeles, California, United States
• Samaritan Center for Medical Research, Medical Group — Los Gatos, California, United States
• Mission Internal Medical Group- Rheumatology Division — Mission Viejo, California, United States
• Investigational Site — Newport Beach, California, United States
• Rheumatology Associates — North Hollywood, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Arthritis Medical Clinic — Riverside, California, United States
• Rheumatology Associates, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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