Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE
The purpose of this study is to determine how B cell subsets and autoantibodies are related to disease remission after rituximab treatment in subjects with Systemic Lupus Erythematosus (SLE).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Rituximab in SLE: Understanding of Long-term Responses and the Impact of B Cell Depletion on T Cells|
- Ratio of B and T cell subsets among those with and without a long-term response and those with and without baseline anti-RBP antibody [ Time Frame: Day 0 through month 24 ] [ Designated as safety issue: Yes ]
- Impact of prolonged B cell absence on the composition and activation status of helper T cell subsets and regulatory T cells [ Time Frame: Day 0 through month 24 ] [ Designated as safety issue: Yes ]
- Effect of B cell depletion on interferon-alpha activity [ Time Frame: Day 0 through month 24 ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
Participants will receive an intravenous infusion of rituximab on Days 0 and 14
1000 mg administered intravenously
Immune cells are an important part of the abnormal autoimmune response in SLE. The B cell is a significant part of this autimmune response because it produces the antibodies which can react with normal tissue of the body. B cells have the ability to accumulate and promote the development of SLE. The purpose of this study is to determine how B cell subsets and autoantibodies are related to disease remission after rituximab treatment in subjects with SLE.
This study will last approximately two years and consist of 15 study visits. These visits will occur at screening, baseline, Days 0 and 14, and Months 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24. Participants will receive a single rituximab injection on Days 0 and 14. Medication history and blood tests will occur at every study visit. A physical exam, medical history, and urine tests will occur at most visits. For females, a pregnancy test will occur at selected visits.
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Study Chair:||Ignacio Sanz, MD||University of Rochester|
|Study Chair:||John Looney, MD||University of Rochester|