Status:
COMPLETED
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
Lead Sponsor:
UCB Pharma
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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)
Detailed Description
Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT01408576
Start Date
July 1 2011
End Date
February 1 2016
Last Update
October 3 2018
Active Locations (228)
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Birmingham, Alabama, United States
2
557
Little Rock, Arkansas, United States
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515
Hemet, California, United States
4
544
Huntington Beach, California, United States