This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Rituximab will be supplied as a liquid for intravenous infusion.
Arizona Arthritis & Rheumatology Research, Pllc
Paradise Valley, Arizona, United States
Eden Medical Center San Leandro Hospital
San Leandro, California, United States
Intermountain Research Center
Boise, Idaho, United States
Percentage of Participants With at Least 1 Serious Adverse Event
A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.
Time frame: Baseline to the end of the study (up to 52 weeks)
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Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology
Great Neck, New York, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Medical Univ of South Carolina
Charleston, South Carolina, United States
Texas Research Center
Sugar Land, Texas, United States
...and 1 more locations