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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01705977




Registration number
NCT01705977
Ethics application status
Date submitted
10/10/2012
Date registered
15/10/2012

Titles & IDs
Public title
Belimumab Assessment of Safety in SLE
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
Secondary ID [1] 0 0
2011-005667-25
Secondary ID [2] 0 0
115467
Universal Trial Number (UTN)
Trial acronym
BASE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Placebo plus standard therapy
Treatment: Other - 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.


Treatment: Other: Placebo plus standard therapy
Placebo plus standard therapy

Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Deaths - On Treatment Period (Week 52)
Timepoint [1] 0 0
Up to Week 52 (On-treatment period)
Primary outcome [2] 0 0
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)
Timepoint [2] 0 0
Up to Week 52 (On-treatment period)
Primary outcome [3] 0 0
Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)
Timepoint [3] 0 0
Up to Week 52 (On-treatment period)
Secondary outcome [1] 0 0
Number of Deaths Reported - On-study Period (Week 52)
Timepoint [1] 0 0
Up to Week 52 (On-study period)
Secondary outcome [2] 0 0
Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)
Timepoint [2] 0 0
Up to Week 52 (On-study period)
Secondary outcome [3] 0 0
Number of Participants With SAEs Reported During On-study Period (Week 52)
Timepoint [3] 0 0
Up to Week 52 (On-study period)
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Week 40 to Week 52
Secondary outcome [5] 0 0
Number of Participants With All-cause Mortality During Years 2 to 5
Timepoint [5] 0 0
From 2 years to 5 years
Secondary outcome [6] 0 0
Number of Participants With New Primary Malignancies During Years 2 to 5
Timepoint [6] 0 0
From 2 years to 5 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/08/2022
Sample size
Target
Accrual to date
Final
4019
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [3] 0 0
GSK Investigational Site - Herston
Recruitment hospital [4] 0 0
GSK Investigational Site - Fitzroy
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2153 - Sydney
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Michigan
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Russian Federation
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Barnaul
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Seville
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Valencia
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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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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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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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Lviv
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Ukraine
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Odesa
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Poltava
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Ternopil
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Uzhgorod
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Vinnytsya
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Ukraine
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Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study is available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/Posting.aspx?ID=20766


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01705977