Last updated: 07/12/2024 08:40:12
Belimumab Assessment of Safety in SLEBASE
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Incidence of all-cause mortality
Timeframe: Up to 52 weeks
Incidence of adverse events of special interest
Timeframe: Up to 52 weeks
Secondary outcomes:
Reduction in prednisone dose
Timeframe: Baseline, Weeks 40 to 52
Interventions:
Enrollment:
4019
Primary completion date:
2018-30-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical 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
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
November 2012 to August 2022
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Active SLE disease.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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).
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.
Trial location(s)
Location
GSK Investigational Site
Angeles City, Pampanga, Philippines, 2009
Status
Study Complete
Location
GSK Investigational Site
Anniston, Alabama, United States, 36207
Status
Study Complete
Location
GSK Investigational Site
Arlington, Virginia, United States, 22205-3606
Status
Study Complete
Showing 1 - 6 of 238 Results
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2018-30-07
Actual study completion date
2022-10-08
Plain language summaries
Summary of results in plain language
Available language(s): English, Bulgarian, Chinese (Malaysia), Chinese (Hong Kong), Croatian, Czech, Estonian, Philippines (Filipino), French (Canadian), German (Switzerland), Hungarian, Indonesian, Italian, Korean, Lithuanian, Malay (Malaysia), Polish, Portuguese (Native), Portuguese (Brazil), Romanian, Russian, Serbian (Latin), Serbian, Slovak, Spanish (Argentina), Spanish (Chile), Spanish (Columbia), Spanish (Mexico), Spanish (Peru), Spanish, Tamil (Malaysia), Thai, Ukrainian, Chinese (Taiwan)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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