drugset / Trial / NCT00101829
Anti-CD20 Antibody Therapy for Sjogren's Syndrome
Phase 1
Completed
12 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 of the anti-CD20 antibody rituximab in treating patients with Sjogren's syndrome (SS). Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with SS, a disease of the immune system. However, the safety of rituximab in SS patients must first be established.
Timeline
- Start
- 2004-04
- Primary completion
- 2006-08
- Completion
- 2009-08
Publications
- Background Boye J, Elter T, Engert A. An overview of the current clinical use of the anti-CD20 monoclonal antibody rituximab. Ann Oncol. 2003 Apr;14(4):520-35. doi: 10.1093/annonc/mdg175.
- Background Cheson BD. Rituximab: clinical development and future directions. Expert Opin Biol Ther. 2002 Jan;2(1):97-110. doi: 10.1517/14712598.2.1.97.
- Background Looney RJ, Anolik J, Sanz I. B cells as therapeutic targets for rheumatic diseases. Curr Opin Rheumatol. 2004 May;16(3):180-5. doi: 10.1097/00002281-200405000-00003.
- Results St Clair EW, Levesque MC, Prak ET, Vivino FB, Alappatt CJ, Spychala ME, Wedgwood J, McNamara J, Moser Sivils KL, Fisher L, Cohen P; Autoimmunity Centers of Excellence. Rituximab therapy for primary Sjogren's syndrome: an open-label clinical trial and mechanistic analysis. Arthritis Rheum. 2013 Apr;65(4):1097-106. doi: 10.1002/art.37850.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 1000 mg | Intravenous |