NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 3

Sponsor: Human Genome Sciences Inc., a GSK Company

Conditions: Systemic Lupus Erythematosus

Interventions: Placebo, Belimumab 200 mg SC, Standard therapy

Countries: United States, Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. At least 18 years of age.
2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
3. Active SLE disease.
4. Autoantibody-positive.
5. 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 Criteria:

1. Pregnant or nursing.
2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
3. Have received treatment an investigational biological agent in the past year.
4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
5. Have severe active lupus kidney disease.
6. Have severe active central nervous system (CNS) lupus.
7. Have required management of acute or chronic infections within the past 60 days.
8. Have current drug or alcohol abuse or dependence.
9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.

Locations (207)

Birmingham, Alabama, United States
Peoria, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
San Jose, California, United States
San Leandro, California, United States
Tustin, California, United States
Upland, California, United States
Bridgeport, Connecticut, United States
Aventura, Florida, United States
Boca Raton, Florida, United States
Boca Raton, Florida, United States
Coral Gables, Florida, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Duluth, Georgia, United States
Lawrenceville, Georgia, United States
Marietta, Georgia, United States
+ 177 more on CT.gov