Status:
COMPLETED
Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Human Genome Sciences Inc.
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
Detailed Description
The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to place...
Eligibility Criteria
Inclusion
- Primary Inclusion Criteria
- Clinical diagnosis of SLE
- "Active" SLE disease
- On a stable SLE treatment regimen
- History of measurable autoantibodies
- Primary Exclusion Criteria
- Received a non-FDA approved investigational agent within last 28 days
- Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days
- Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (\> 100 mg/day) within last 90 days
- Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days
- History of renal transplant
- History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days
- History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
- Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
449 Patients enrolled
Trial Details
Trial ID
NCT00071487
Start Date
October 1 2003
End Date
June 1 2006
Last Update
August 7 2013
Active Locations (62)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
2
Arizona Arthritis Research
Paradise Valley, Arizona, United States, 85253
3
University of Arizona
Tucson, Arizona, United States, 85724
4
Scripps Clinic
La Jolla, California, United States, 92037