A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Genome Sciences Inc., a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Belimumab

Criteria

Inclusion Criteria:

• Clinical diagnosis of SLE by ACR criteria.

• Active SLE disease.

• Autoantibody-positive.

• On stable SLE treatment regimen.

Exclusion Criteria:

• 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.