A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)

Completed · Phase 3 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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).

Key facts

Study ID

NCT01484496

Run by

Human Genome Sciences Inc., a GSK Company

People needed

839

Starts

2011-11-16

Expected to finish

2015-10-01

Last updated by the study team

2018-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Peoria, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — San Leandro, California, United States
• GSK Investigational Site — Tustin, California, United States
• GSK Investigational Site — Upland, California, United States
• GSK Investigational Site — Bridgeport, Connecticut, United States
• GSK Investigational Site — Aventura, Florida, United States
• GSK Investigational Site — Boca Raton, Florida, United States
• GSK Investigational Site — Boca Raton, Florida, United States
• GSK Investigational Site — Coral Gables, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Plantation, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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