Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

Stopped early · Phase 2

Conditions studied: Systemic Lupus Erythematosus

In brief

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

Key facts

Study ID

NCT00732940

Run by

Human Genome Sciences Inc.

People needed

56

Starts

2008-10-01

Expected to finish

2012-03-01

Last updated by the study team

2013-08-07

Who can join

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

You may qualify if…

• Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
• Active SLE disease
• On stable SLE treatment regimen

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Valerious Medical Group Research Center — Long Beach, California, United States
• Tampa Medical Group, PA — Tampa, Florida, United States
• Fiechtner Research, Inc. — Lansing, Michigan, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• North Shore-LIJ Health System/Rheumatology, Allergy, Immunology — Lake Success, New York, United States
• Rheumatology Associates — Smithtown, New York, United States
• STAT Research, Inc. — Dayton, Ohio, United States
• Oklahoma Center for Arthritis Therapy & Research — Tulsa, Oklahoma, United States
• Houston Institute for Clinical Research — Houston, Texas, United States
• Hospital Central "Igancio Morones Prieto" — San Lusi Potosi, Mexico

Full record on ClinicalTrials.gov

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