drugset / Trial / NCT00624351
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.
Timeline
- Start
- 2008-01
- Primary completion
- 2009-08
- Completion
- 2009-08
Publications
- Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Wallace DJ, Kalunian K, Petri MA, Strand V, Houssiau FA, Pike M, Kilgallen B, Bongardt S, Barry A, Kelley L, Gordon C. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. 2014 Jan;73(1):183-90. doi: 10.1136/annrheumdis-2012-202760. Epub 2013 Jan 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epratuzumab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Epratuzumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | Epratuzumab | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Epratuzumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Epratuzumab | Monoclonal antibody | 1800 mg | Intravenous |