Status:
COMPLETED
A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
Lead Sponsor:
Human Genome Sciences Inc., a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Lupus Erythematosus, Discoid
Eligibility:
All Genders
18+ years
Brief Summary
Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled Analysis of the HGS1006-C1...
Detailed Description
Studies C1056 and C1057 followed very similar protocols, were of nearly identical design, had common inclusion and exclusion criteria, and were conducted over the same time period. Nevertheless, given...
Eligibility Criteria
Inclusion
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen.
Exclusion
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
- Have received treatment with a biological investigational agent in the past year.
- Have received 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 within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01858792
Start Date
May 1 2011
End Date
June 1 2011
Last Update
May 21 2013
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