Status:
TERMINATED
Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Human Genome Sciences Inc.
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.
Detailed Description
This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an explora...
Eligibility Criteria
Inclusion
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
- Active SLE disease
- On stable SLE treatment regimen
Exclusion
- Pregnant or nursing
- Have received treatment with an B cell targeted therapy
- Have received treatment with a biologic investigational agent in the past year
- Have received intravenous (IV) cyclophosphamide within 180 days of Day 0
- Have severe lupus kidney disease
- Have active central nervous system (CNS) lupus
- Have required management of acute or chronic infections with the past 60 days
- Have current drug or alcohol abuse or dependence or within the past year
- Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00732940
Start Date
October 1 2008
End Date
March 1 2012
Last Update
August 7 2013
Active Locations (11)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249-7201
2
Valerious Medical Group Research Center
Long Beach, California, United States, 90806
3
Tampa Medical Group, PA
Tampa, Florida, United States, 33614
4
Fiechtner Research, Inc.
Lansing, Michigan, United States, 48910