Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial Description

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. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01702038
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Withdrawn
Phase Phase 2
Start date September 2009

See also
  Status Clinical Trial Phase
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Recruiting NCT05967520 - JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus Phase 2
Completed NCT02875691 - Effect of Green Tea on Treatment of Lupus Phase 2
Completed NCT02922114 - Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients N/A
Terminated NCT00368264 - TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL ) Phase 2/Phase 3
Completed NCT00094380 - Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077) Phase 1/Phase 2
Completed NCT00065806 - Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) Phase 3
Completed NCT00005436 - Lupus Cohort--Thrombotic Events and Coronary Artery Disease N/A
Recruiting NCT03543839 - Trial of Belimumab in Early Lupus Phase 4
Completed NCT03098823 - A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE Phase 4
Recruiting NCT05899907 - Efficacy and Safety of Telitacicept in Early SLE Phase 4
Completed NCT04956484 - Belimumab In Early Systemic Lupus Erythematosus Phase 4
Completed NCT05326841 - Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients . Phase 3
Completed NCT02655640 - The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis N/A
Completed NCT02034344 - A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers Phase 0
Terminated NCT00089804 - Study of LJP 394 in Lupus Patients With History of Renal Disease Phase 3
Completed NCT00071487 - Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE) Phase 2
Completed NCT02349061 - A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus Phase 2
Recruiting NCT05636670 - Assessment of Cognitive Function and Gut Microbiota Analysis in Real World Patients With Lupus Cerebrovascular Disease
Recruiting NCT03747159 - Synergetic B-cell Immunomodulation in SLE - 2nd Study. Phase 3