Status:
COMPLETED
A Study of Belimumab in 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:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects ...
Eligibility Criteria
Inclusion
- Key
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen.
- Key
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 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
865 Patients enrolled
Trial Details
Trial ID
NCT00424476
Start Date
May 1 2007
End Date
March 1 2010
Last Update
December 12 2016
Active Locations (92)
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1
OMI, Organización Médica de Investigación
Buenos Aires, Argentina, C1015ABO
2
CIER, Centro de Investigaciones en Enfermedades Reumáticas
Buenos Aires, Argentina, C1055AAF
3
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina, C1280AEB
4
Hospital General de Agudos Carlos G. Durand
Buenos Aires, Argentina, C1405DCS