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Clinical Study Information - epratuzumab

Disease area
studied
Abbreviated title Phase Study ID Registry database Study results Study summary Publication (if available)
Systemic Lupus Erythematosus
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE) Phase 2 SL0002
Terminated
NCT00113971 Hobbs et al. Ann Rheum Dis. 2011;70(Suppl 3):319, abs THU0425.
European League Against Rheumatism (EULAR) 2011. May 25-28, 2011;London, UK.
Systemic Lupus Erythematosus Study of Epratuzumab in Systemic Lupus Erythematosus Phase 3 SL0003
Terminated
NCT00111306
2005-000705-59
Wallace et al. Rheumatology (Oxford);2013;52(7);1313-1322.
Systemic Lupus Erythematosus Study of Epratuzumab in Systemic Lupus Erythematosus (SLE) Phase 3 SL0004
Terminated
NCT00383214
2005-000706-31
Wallace et al. Rheumatology (Oxford);2013;52(7);1313-1322.
Systemic Lupus Erythematosus Study of Epratuzumab in Systemic Lupus Erythematosus Phase 3 SL0005
Terminated
NCT00382837
Systemic Lupus Erythematosus Study of Epratuzumab in Systemic Lupus Erythematosus Phase 2 SL0006
Completed
NCT00383513 Wallace et al. Rheumatology (Oxford);2013;52(7);1313-1322.
Systemic Lupus Erythematosus Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease Phase 2 SL0007
Completed
NCT00624351
2007-002566-35
Wallace et al. Ann Rheum Dis; 2014;73(1); 183-190.
Systemic Lupus Erythematosus Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Phase 2 SL0008
Completed
NCT00660881
2007-002589-37
Wallace, D. J. et al. Arthritis Care Res (Hoboken);2016; 68;4;534-543
Systemic Lupus Erythematosus Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (EMBODY 1) Phase 3 SL0009
Completed
NCT01262365
2010-018563-41

LINK
Clowse et al.  Arthritis Rheumatol; 2017; 69(2): 362-377
Systemic Lupus Erythematosus Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) (EMBODY 2) Phase 3 SL0010
Completed
NCT01261793
2010-018565-26

LINK
Clowse et al.  Arthritis Rheumatol; 2017; 69(2): 362-377
Systemic Lupus Erythematosus Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus (EMBODY4) Phase 3 SL0012
Ongoing
NCT01408576
2010-020859-30

LINK

Systemic Lupus Erythematosus Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Phase 2 SL0026
Completed
NCT01449071 Yamamoto et al. Ann Rheum Dis. 2014;73(suppl.2):526, abs. FRI0383.
European League Against Rheumatism (EULAR) 2014. June 11-14, 2014;Paris, France.
Systemic Lupus Erythematosus Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects Phase 2 SL0027
Completed
NCT01534403