Full Text View
Tabular View
No Study Results Posted
Related Studies
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
This study is ongoing, but not recruiting participants.
Study NCT00410384   Information provided by Human Genome Sciences
First Received: December 8, 2006   Last Updated: February 19, 2009   History of Changes

December 8, 2006
February 19, 2009
December 2006
February 2010   (final data collection date for primary outcome measure)
At Wk 52 the % of subjects with great than or equal to 4 point reduction from baseline in SELENA SLEDAI score & no worsening in PGA & no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
The primary efficacy endpoint is response rate at Week 52.
Complete list of historical versions of study NCT00410384 on ClinicalTrials.gov Archive Site
  • At Wk 76, % of subjects with great than or equal to 4 point reduction from baseline in SELENA SLEDAI score & no worsening in (PGA) and no new BILAG organ domain score or 2 new BILAG organ domain scores compared with baseline at the time of assessment. [ Time Frame: 76 Weeks ] [ Designated as safety issue: No ]
  • Percent of subjects with great than or equal to 4 point reduction from baseline in SELENA SLEDAI score at Wk 52. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Mean change in PGA at Wk 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Mean change in SF-36 Health Survey physical component summary score (PCS) at Wk 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Percent of subjects whose average prednisone dose has been reduced by greater than or equal to 25% from baseline to less than or equal to 7.5 mg/day during Weeks 40 through 52 [ Time Frame: Weeks 40-52 ] [ Designated as safety issue: No ]
  • The major secondary outcome measures include
  • SELENA SLEDAI
  • Physicians Global Assessment
  • quality of life
  • prednisone usage
 
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
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 SLE disease.

The purpose of this SLE trial 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 Systemic Lupus Erythematosus (SLE) disease.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Systemic Lupus Erythematosus
  • Drug: belimumab
  • Drug: Placebo
  • Experimental: 1mg/kg
  • Experimental: 10mg/kg
  • Placebo Comparator: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
810
February 2010
February 2010   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Clinical diagnosis of SLE by ACR criteria.
  • Active SLE disease.
  • On stable SLE treatment regimen.

Key Exclusion Criteria:

  • Pregnant or nursing
  • Have received treatment with any B cell targeted therapy.
  • Have received treatment with a biological investigational agent in the past year.
  • Have received IV cyclophosphamide within 180 days of Day 0.
  • Have severe lupus kidney disease.
  • Have active central nervous system (CNS) lupus.
  • Have required management of acute or chronic infections within the past 60 days.
  • Have current drug or alcohol abuse or dependence.
  • Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   Costa Rica,   Czech Republic,   France,   Germany,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Romania,   Slovakia,   Spain,   Sweden,   United Kingdom
 
NCT00410384
William Freimuth, MD, PhD/Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences, Inc.
HGS1006-C1056, BLISS-76
Human Genome Sciences
GlaxoSmithKline
Study Director: William Freimuth, MD, PhD Human Genome Sciences, Inc.
Human Genome Sciences
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP