Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Epratuzumab

Criteria

Inclusion Criteria:

• Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment

• Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment

• Women of childbearing potential must agree to use an acceptable method of birth control

Exclusion Criteria:

• Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease

• Subjects with active, severe SLE disease activity which involves the renal system

• Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections

• Substance abuse or dependence

• History of malignant cancer

• Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion