drugset / Trial / NCT00036491
Anti-CD20 in Systemic Lupus Erythematosus
Phase 1/2
Completed
24 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2001-01
- Primary completion
- 2006-01
- Completion
- 2006-01
Publications
- Background Eisenberg R. Targeting B cells in SLE: the experience with rituximab treatment (anti-CD20). Endocr Metab Immune Disord Drug Targets. 2006 Dec;6(4):345-50. doi: 10.2174/187153006779025757.
- Background Sutter JA, Kwan-Morley J, Dunham J, Du YZ, Kamoun M, Albert D, Eisenberg RA, Luning Prak ET. A longitudinal analysis of SLE patients treated with rituximab (anti-CD20): factors associated with B lymphocyte recovery. Clin Immunol. 2008 Mar;126(3):282-90. doi: 10.1016/j.clim.2007.11.012. Epub 2008 Jan 15.
- Results Albert D, Dunham J, Khan S, Stansberry J, Kolasinski S, Tsai D, Pullman-Mooar S, Barnack F, Striebich C, Looney RJ, Prak ET, Kimberly R, Zhang Y, Eisenberg R. Variability in the biological response to anti-CD20 B cell depletion in systemic lupus erythaematosus. Ann Rheum Dis. 2008 Dec;67(12):1724-31. doi: 10.1136/ard.2007.083162. Epub 2008 Feb 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |