A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: belimumab Drug: Placebo	Phase III

MedlinePlus related topics:

Lupus

ChemIDplus related topics:

Belimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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)

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

At Wk 52, percent of subjects with ≥4 point reduction from baseline in SELENA SLEDAI score and 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: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

At Wk 76, percent of subjects with ≥4 point reduction from baseline in SELENA SLEDAI score and 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 ≥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 ]

Estimated Enrollment:	810
Study Start Date:	December 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 1mg/kg	Drug: belimumab 1mg/kg, IV (in the vein) on Days 0, 14, 28, and every 28 days through 72 weeks with a final evaluation at Week 76. 10mg/kg, IV (in the vein) on Days 0, 14, 28, and every 28 days through 72 weeks with a final evaluation at Week 76.
2: Active Comparator 10mg/kg	Drug: belimumab 1mg/kg, IV (in the vein) on Days 0, 14, 28, and every 28 days through 72 weeks with a final evaluation at Week 76. 10mg/kg, IV (in the vein) on Days 0, 14, 28, and every 28 days through 72 weeks with a final evaluation at Week 76.
3: Placebo Comparator Placebo	Drug: Placebo Days 0, 14, 28, and every 28 days through 72 weeks

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410384

Contacts


Contact: Dan Odenheimer, PhD.	1-866-447-9749	dan_odenheimer@hgsi.com

Show 157 Study Locations

Sponsors and Collaborators

Human Genome Sciences

GlaxoSmithKline

Investigators


Study Director:	William Freimuth, MD, PhD	Human Genome Sciences, Inc.

More Information

www.bliss-study.com This link exits the ClinicalTrials.gov site

Responsible Party:	Human Genome Sciences, Inc. ( William Freimuth, MD, PhD/Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases )
Study ID Numbers:	HGS1006-C1056, BLISS-76
First Received:	December 8, 2006
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00410384
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Mexico: Ministry of Health; Germany: Paul-Ehrlich-Institut; Belgium: Ministry of Social Affairs, Public Health and the Environment; Netherlands: Independent Ethics Committee; Czech Republic: State Institute for Drug Control; Slovakia: State Institute for Drug Control; United Kingdom: Department of Health; France: Ministry of Health; Spain: Ministry of Health; Poland: Ministry of Health; Italy: Ministry of Health; Austria: Agency for Health and Food Safety; Israel: Ministry of Health; Sweden: Medical Products Agency

Keywords provided by Human Genome Sciences:

Lupus

SLE

Systemic Lupus Erythematosus

Study placed in the following topic categories:

Antibodies

Autoimmune Diseases

Lupus Erythematosus, Systemic

Additional relevant MeSH terms:

Immune System Diseases

Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 03, 2008

Sponsors and Collaborators:	Human Genome Sciences GlaxoSmithKline
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00410384