Overview

This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatment belimumab
Phase phase 3
Sponsor Human Genome Sciences Inc., a GSK Company
Collaborator GlaxoSmithKline
Start date May 2008
End date October 2016
Trial size 738 participants
Trial identifier NCT00712933, 112234

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
1 mg/kg dose of belimumab given IV every 28 days.
belimumab LymphoStat-B™
Recombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.
(Experimental)
10 mg/kg dose of belimumab given IV every 28 days.
belimumab LymphoStat-B™
Recombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.

Primary Outcomes

Measure
To evaluate the long-term safety of belimumab (LymphoStat-B™) in subjects with SLE
time frame: Until study completion

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively. Exclusion Criteria: - Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.

Additional Information

Official title 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
Description This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.