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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/NCT01705977
Registration number
NCT01705977
Ethics application status
Date submitted
10/10/2012
Date registered
15/10/2012
Date last updated
31/08/2023
Titles & IDs
Public title
Belimumab Assessment of Safety in SLE
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
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Secondary ID [1]
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0
2011-005667-25
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Secondary ID [2]
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115467
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Universal Trial Number (UTN)
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Trial acronym
BASE
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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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0
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Condition category
Condition code
Human Genetics and Inherited Disorders
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0
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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
Other interventions - Placebo plus standard therapy
Other interventions - Belimumab 10 mg/kg plus standard therapy
Other interventions - Standard therapy
Placebo Comparator: Placebo plus standard therapy - Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.
Experimental: Belimumab 10 mg/kg plus standard therapy - Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.
Other interventions: Placebo plus standard therapy
Placebo plus standard therapy
Other interventions: Belimumab 10 mg/kg plus standard therapy
Belimumab 10 mg/kg plus standard therapy
Other interventions: Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.
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Intervention code [1]
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Other interventions
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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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Number of Deaths - On Treatment Period (Week 52)
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Assessment method [1]
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Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than [>]50 percent [%]) of the time. The on-treatment period was the primary analysis period for safety analyses.
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Timepoint [1]
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Up to Week 52 (On-treatment period)
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Primary outcome [2]
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Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)
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Assessment method [2]
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A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale [C-SSRS]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.
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Timepoint [2]
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Up to Week 52 (On-treatment period)
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Primary outcome [3]
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Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)
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Assessment method [3]
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An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.
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Timepoint [3]
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Up to Week 52 (On-treatment period)
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Secondary outcome [1]
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Number of Deaths Reported - On-study Period (Week 52)
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Assessment method [1]
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Number of participants who died during on-study period (Week 52) is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.
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Timepoint [1]
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Up to Week 52 (On-study period)
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Secondary outcome [2]
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Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)
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Assessment method [2]
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A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.
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Timepoint [2]
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Up to Week 52 (On-study period)
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Secondary outcome [3]
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Number of Participants With SAEs Reported During On-study Period (Week 52)
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Assessment method [3]
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A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses.
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Timepoint [3]
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Up to Week 52 (On-study period)
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Secondary outcome [4]
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Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE 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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The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage of participants whose average prednisone dose has been reduced by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52 in participants with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (<=9 versus >=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1).
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Timepoint [4]
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Week 40 to Week 52
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Secondary outcome [5]
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Number of Participants With All-cause Mortality During Years 2 to 5
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Assessment method [5]
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Number of participants with all-cause mortality during years 2 to 5 has been presented.
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Timepoint [5]
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From 2 years to 5 years
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Secondary outcome [6]
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Number of Participants With New Primary Malignancies During Years 2 to 5
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Assessment method [6]
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Number of participants with new primary malignancies during years 2 to 5 has been presented.
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Timepoint [6]
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From 2 years to 5 years
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Eligibility
Key inclusion criteria
Key
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen which may include corticosteroids (for example,
prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants
(for example, azathioprine, methotrexate, mycophenolate).
Key
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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 of the following: belimumab, either as a marketed
product or as an investigational agent; any B cell targeted therapy (for example,
rituximab) in the past year; or any biological agent (for example, adalimumab,
etanercept, infliximab, or anakinra) in the past 90 days.
- Have received a live vaccine within the past 30 days.
- Have severe active lupus kidney disease.
- Have severe active central nervous system (CNS) lupus.
- Current or past positive for human immunodeficiency virus (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 administering the treatment/s
The people assessing the outcomes
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 4
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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
27/11/2012
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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
10/08/2022
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Sample size
Target
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Accrual to date
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Final
4019
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Garran
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Recruitment hospital [2]
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GSK Investigational Site - Sydney
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Recruitment hospital [3]
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GSK Investigational Site - Herston
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Recruitment hospital [4]
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GSK Investigational Site - Fitzroy
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2153 - Sydney
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment outside Australia
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United States of America
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Alabama
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Michigan
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Mississippi
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Auckland
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New Zealand
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Wellington
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Peru
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Arequipa
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Peru
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State/province [108]
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Lima
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Philippines
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State/province [109]
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Angeles City, Pampanga
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Philippines
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Cebu City
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Davao City
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Philippines
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Iloilo City
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Philippines
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Las Pinas
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Philippines
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Manila
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Philippines
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Quezon City
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Krakow
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Portugal
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Almada
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Viseu
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Romania
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Bucharest
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Romania
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Galati
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Romania
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Targu Mures
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Russian Federation
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Barnaul
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Russian Federation
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Kemerovo
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Serbia
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Belgrade
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Serbia
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Krusevac
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Serbia
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Niska Banja
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Serbia
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Sabac
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Slovakia
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Piestany
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Spain
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Barcelona
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Bilbao
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Spain
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Castellón
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Spain
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Cordoba
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Spain
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Getafe/Madrid
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Granada
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Spain
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Madrid
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Spain
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Malaga
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Sevilla
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Spain
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Seville
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Spain
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Valencia
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Vilajoyosa
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Switzerland
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St. Gallen
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Switzerland
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Zuerich
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Taiwan
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Chiayi County
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Taiwan
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Gueishan Township,Taoyuan County
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taipei
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Bangkok
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Thailand
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Chiang Mai
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Country [160]
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Ukraine
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Chernivtsi
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Ukraine
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Donetsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Poltava
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Ukraine
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Ternopil
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Ukraine
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Uzhgorod
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Vinnytsia
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Ukraine
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Vinnytsya
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Ukraine
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Zaporizhzhia
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Funding & Sponsors
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Commercial sector/Industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
The purpose of this study is to further enhance the existing knowledge regarding the side
effects of belimumab when given with other lupus medicines to adults with active systemic
lupus erythematosus (SLE). This study mainly focuses on collecting information on serious
events that are not that common or may only be seen with long-term treatment. These events
include death, serious infections and other infections of interest, cancers, serious mental
health problems, including depression and suicide, and serious infusion and hypersensitivity
reactions. This study is being done to help understand if treatment with belimumab increases
the risk for these types of events. This study will also see if patients receiving belimumab
with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01705977
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Trial related presentations / publications
Sheikh S, Scheinberg MA, Wei CC, Tegzova D, Stohl W, Acayaba de Toledo R, Mucenic T, Abello M, Maksimowicz-McKinnon K, Abud Mendoza C, Navarra S, Garcia M, Garcia de la Torre I, Ordi Ros J, Nami A, Levy R, Bass D, Ross J, Punwaney R, Harris J, Pierce A, Thorneloe K, Ji B, Roth D. Mortality and adverse events of special interest in adult patients with active, auto-antibody-positive systemic lupus erythematosus receiving intravenous belimumab (BASE): a global, randomised, double-blind, placebo-controlled, multicentre Phase 4 trial. Lancet Rheumatol. 2020; DOI: 10.1016/S2665-9913(20)30355-6
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Public notes
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Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01705977
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