Clinical Trials Directory

Trials / Completed

CompletedNCT00712933

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

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 or HGS1006-C1057

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

Summary

This is a long-term continuation study to provide continuing treatment to subjects with SLE.

Detailed description

This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).

Conditions

Interventions

TypeNameDescription
DRUGbelimumabRecombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.

Timeline

Start date
2008-05-30
Primary completion
2016-12-09
Completion
2016-12-09
First posted
2008-07-10
Last updated
2019-12-05
Results posted
2018-01-16

Locations

110 sites across 28 countries: Argentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, France, Germany, Hong Kong, India, Israel, Italy, Mexico, Netherlands, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom

Source: ClinicalTrials.gov record NCT00712933. Inclusion in this directory is not an endorsement.