Status:
COMPLETED
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Human Genome Sciences Inc., a GSK Company
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 and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).
Detailed Description
This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (...
Eligibility Criteria
Inclusion
- At least 18 years of age.
- Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)
Exclusion
- Pregnant or nursing.
- Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
- Have received treatment an investigational biological agent in the past year.
- Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
- Have severe active lupus kidney disease.
- Have severe 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 positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Have a history of hypersensitivity reactions to contrast agents or biological medicines.
Key Trial Info
Start Date :
November 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
839 Patients enrolled
Trial Details
Trial ID
NCT01484496
Start Date
November 16 2011
End Date
October 1 2015
Last Update
June 6 2018
Active Locations (207)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294
2
GSK Investigational Site
Peoria, Arizona, United States, 85381
3
GSK Investigational Site
Tucson, Arizona, United States, 85712
4
GSK Investigational Site
Tucson, Arizona, United States, 85724