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A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Research, PPLC
Paradise Valley, Arizona, United States
The University of Arizona Arthritis Center
Tucson, Arizona, United States
Talbert Medical Group
Huntington Beach, California, United States
Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
Long Beach, California, United States
University of Southern California
Los Angeles, California, United States
Wallace Rheumatic Study Center
Los Angeles, California, United States
UCLA Rheumatology
Los Angeles, California, United States
Arthritis Care Center, Inc.
San Jose, California, United States
Inland Rheumatic Disease Specialties
Upland, California, United States
Start Date
December 1, 2006
Primary Completion Date
September 1, 2009
Completion Date
March 1, 2010
Last Updated
February 1, 2017
819
ACTUAL participants
Placebo
DRUG
Belimumab 1 mg/kg
DRUG
Belimumab 10 mg/kg
DRUG
Lead Sponsor
Human Genome Sciences Inc.
Collaborators
NCT06647069
NCT07371468
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06333483