Status:
COMPLETED
Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Human Genome Sciences Inc.
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.
Eligibility Criteria
Inclusion
- Key
- Clinical diagnosis of SLE by ACR criteria
- Stable SLE disease activity
- On stable SLE treatment regimen
- History of measurable autoantibodies
- Key
Exclusion
- Pregnant or nursing
- Received a non-FDA approved investigational agent within last 28 days
- Received cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 6 months
- Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan™), or high-dose prednisone (\> 100 mg/day) within last 6 months
- Active central nervous system (CNS) lupus requiring medical intervention within last 6 months
- History of renal transplant
- History of clinical evidence of an active significant acute or chronic diseases
- Have required management or hospitalization of any infection within last 4 weeks.
- History of hypogammaglobulinemia or IgA deficiency
- Have current drug or alcohol addiction
- History of or test positive at screening for HIV, Hepatitis B or Hepatitis C
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00657007
Start Date
February 1 2002
End Date
March 1 2003
Last Update
August 2 2013
Active Locations (18)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Southern California
Los Angeles, California, United States, 90033
3
University of California-Los Angeles
Los Angeles, California, United States, 90095
4
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010