NCT00724867

A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Human Genome Sciences Inc., a GSK Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.

Detailed description

This is a long-term continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States. This study is to evaluate the long-term safety and efficacy of belimumab (LymphoStat-B™) in subjects with SLE disease.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV over one hour every 28 days
BIOLOGICAL	Belimumab 10 mg/kg	Belimumab 10 mg/kg IV over one hour every 28 days

Timeline

• Start date: 2008-08-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2008-07-30
• Last updated: 2016-03-28
• Results posted: 2016-03-28

Locations

51 sites across 1 country: United States