Anti-CD20 in Systemic Lupus Erythematosus
The purpose of this study is to determine the safety and effectiveness of rituximab (anti-CD20) in treating systemic lupus erythematosus (SLE).
White blood cells in the body called B cells give off substances that are active in promoting SLE disease. Researchers have found that anti-CD20 can block production of these substances in another disease. This study explores whether anti-CD20 will also be safe in people with SLE and whether it may be effective in treating SLE.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus Erythematosus|
- Serum Autoantibodies [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56 ] [ Designated as safety issue: No ]
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55 ] [ Designated as safety issue: No ]
- C3 and C4 complement levels [ Designated as safety issue: Yes ]
- Systemic Lupus Activity Measure (SLAM) [ Time Frame: Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55 ] [ Designated as safety issue: No ]
- Erythrocyte Sedimentation Rate (ESR) [ Designated as safety issue: Yes ]
- Prednisone Dose [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56 ] [ Designated as safety issue: No ]
- Renal Function [ Designated as safety issue: Yes ]Measured by creatinine clearance and total protein.
- Modified Health Assessment Questionnaire (HAQ) [ Designated as safety issue: No ]
- Short Form-36 Health Survey (SF-36) [ Designated as safety issue: No ]
- Physician Global Assessment (VAS) [ Designated as safety issue: No ]
- Patient Global Assessment (VAS) [ Designated as safety issue: No ]
- Systemic Lupus Erythematosus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index for SLE [ Designated as safety issue: No ]
- Adverse Events [ Designated as safety issue: Yes ]
|Study Start Date:||January 2001|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
375 mg/m^2 administered intravenously
Subjects received four weekly infusions of rituximab at a dose of 375 mg/m^2
Other Name: Rituxan®
B cells clearly play an essential role in the pathogenesis of SLE since they produce autoantibodies. Clinical observations support the contention that intervening in the production of autoantibodies by the B lymphocyte will be effective therapy. Current approved therapy for B-cell non-Hodgkin's lymphoma includes anti-CD20. The results of anti-CD20 administration in SLE are anticipated to be similar to those in lymphoma patients. The current proposal explores the mechanisms and applicability of B-cell depletion as a potential treatment for SLE.
Participants receive 4 weekly infusions of study medication. Each participant is enrolled in the study for a total of 1 year with protocol visits weekly for the first 3 months, then every other week for the next 2 months, every month for the next 4 months, and every other month for the remaining 5 months of the study (Weeks 0, 1, 2, 3, 4, 5, 6, 7, 9, 11, 13, 15, 19, 23, 27, 31, 39, 47, and 55). Responses to exogenous antigens are measured; assessments for clinical response with SLE-disease activity score (SLEDEI) and systemic lupus activity measure (SLAM) score are performed. Participants complete a health questionnaire and a health survey and laboratory parameters are evaluated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036491
|United States, Colorado|
|University of Colorado|
|Denver, Colorado, United States, 80045|
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14623|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Robert A. Eisenberg, MD||University of Pennsylvania|