Status:
COMPLETED
Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
Lead Sponsor:
UCB Pharma
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
Eligibility Criteria
Inclusion
- SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
- Patients must have maintained eligibility requirements throughout their participation in SL0007
- Written informed consent signed prior to initiation of any study-specific assessments at visit 1
Exclusion
- Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study
- Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
- Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine \>2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria \>3.5gm/day
- Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment
- Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00660881
Start Date
May 1 2008
End Date
December 1 2011
Last Update
July 12 2012
Active Locations (42)
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1
Birmingham, Alabama, United States
2
Tucson, Arizona, United States
3
La Jolla, California, United States
4
Los Angeles, California, United States