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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00424476
Registration number
NCT00424476
Ethics application status
Date submitted
17/01/2007
Date registered
19/01/2007
Date last updated
12/12/2016
Titles & IDs
Public title
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
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Scientific 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)
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Secondary ID [1]
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BLISS-52
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Secondary ID [2]
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HGS1006-C1057
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Universal Trial Number (UTN)
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Trial acronym
BLISS-52
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Belimumab 1 mg/kg
Treatment: Drugs - Belimumab 10 mg/kg
Placebo Comparator: Placebo - Placebo
Experimental: Belimumab 1 mg/kg - Belimumab 1 mg/kg
Experimental: Belimumab 10 mg/kg - Belimumab 10 mg/kg
Treatment: Drugs: Placebo
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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SLE Responder Index (SRI) Response Rate at Week 52
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline, 52 weeks
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Secondary outcome [1]
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Percent of Subjects With a = 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.
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Assessment method [1]
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Timepoint [1]
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Baseline, 52 weeks
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Secondary outcome [2]
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Mean Change in Physician's Global Assessment (PGA) at Wk 24.
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, 24 weeks
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Secondary outcome [3]
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Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, 24 weeks
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Secondary outcome [4]
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Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by = 25% From Baseline to = 7.5 mg/Day During Weeks 40 Through 52
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Assessment method [4]
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Timepoint [4]
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Baseline, Weeks 40 through 52
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Eligibility
Key inclusion criteria
Key
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2010
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Sample size
Target
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Accrual to date
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Final
865
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Repatriation Hospital - Daw Park
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Recruitment hospital [2]
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Emeritus Research, Cabrini Hospital - Melbourne
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Recruitment hospital [3]
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Monash Medical Centre - Melbourne
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Recruitment hospital [4]
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Royal Perth Hospital - Shenton Park
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Recruitment postcode(s) [1]
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5041 - Daw Park
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Recruitment postcode(s) [2]
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3144 - Melbourne
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Recruitment postcode(s) [3]
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3168 - Melbourne
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Recruitment postcode(s) [4]
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6008 - Shenton Park
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Recruitment outside Australia
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Argentina
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State/province [1]
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Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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La Plata
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Fortaleza
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Brazil
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Goiânia
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Juiz de Fora
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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São Paulo
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Chile
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Santiago
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Chile
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Viña del Mar
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Colombia
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Lucknow
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Human Genome Sciences Inc.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00424476
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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Human Genome Sciences Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00424476
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