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

Sponsor:	Human Genome Sciences
Collaborator:	GlaxoSmithKline
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00424476

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, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: Placebo Drug: Belimumab 1 mg/kg Drug: Belimumab 10 mg/kg	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk 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)

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases Lupus

Drug Information available for: Belimumab

U.S. FDA Resources

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

SLE Responder Index (SRI) Response Rate at Week 52 [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

Secondary Outcome Measures:

Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52. [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Mean Change in Physician's Global Assessment (PGA) at Wk 24. [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24. [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52 [ Time Frame: Baseline, Weeks 40 through 52 ] [ Designated as safety issue: No ]

Enrollment:	865
Study Start Date:	May 2007
Study Completion Date:	March 2010
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Experimental: Belimumab 1 mg/kg	Drug: Belimumab 1 mg/kg Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48. Other Name: BENLYSTA™ (formerly LymphoStat-B™)
Experimental: Belimumab 10 mg/kg	Drug: Belimumab 10 mg/kg Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48. Other Name: BENLYSTA™ (formerly LymphoStat-B™)

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.
Autoantibody-positive.
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: NCT00424476

Show 92 Study Locations

Sponsors and Collaborators

Human Genome Sciences

GlaxoSmithKline

Investigators

Study Director:

William Freimuth, MD, PhD

Human Genome Sciences, Inc.

More Information

No publications provided by Human Genome Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Navarra SV, Guzmán RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, León MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA; BLISS-52 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Feb 26;377(9767):721-31. Epub 2011 Feb 4.

Responsible Party:	William Freimuth, MD, PhD/Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences, Inc.
ClinicalTrials.gov Identifier:	NCT00424476 History of Changes
Other Study ID Numbers:	HGS1006-C1057, BLISS-52
Study First Received:	January 17, 2007
Results First Received:	April 7, 2011
Last Updated:	June 3, 2011
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Therapeutic Goods Administration Brazil: National Health Surveillance Agency Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Hong Kong: Department of Health India: Drugs Controller General of India Korea: Food and Drug Administration Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Philippines: Bureau of Food and Drugs Romania: Ministry of Public Health Russia: Ministry of Health and Social Development of the Russian Federation Taiwan: Department of Health United States: Food and Drug Administration

Keywords provided by Human Genome Sciences:

SLE
Lupus
Systemic Lupus Erythematosus

Antibodies
Autoimmune Diseases
Belimumab

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2012