NCT00583362

A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 298 (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 evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

Detailed description

The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.

Conditions

• Systemic Lupus Erythematosus

Interventions

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

Timeline

• Start date: 2005-05-04
• Primary completion: 2016-02-23
• Completion: 2016-02-23
• First posted: 2007-12-31
• Last updated: 2019-07-23
• Results posted: 2017-04-28

Locations

57 sites across 2 countries: United States, Canada