Status:
COMPLETED
Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
UCB Pharma
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of ca...
Eligibility Criteria
Inclusion
- Positive Anti-nuclear Antibody (ANA) at Screening (Visit 1)
- Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria
- Active moderate to severe SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG)
- Active moderate to severe SLE disease as demonstrated by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score on stable SLE treatment
Exclusion
- Subjects who are breastfeeding, pregnant, or plan to become pregnant
- Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A
- Serious infections
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01449071
Start Date
October 1 2011
End Date
March 1 2013
Last Update
February 12 2014
Active Locations (7)
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1
09
Fukuoka, Japan
2
10
Fukuoka, Japan
3
11
Fukuoka, Japan
4
03
Kitakyushu, Japan