Last updated: 07/12/2024 08:40:12
Belimumab Assessment of Safety in SLEBASE
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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:
Biological/vaccine: Placebo plus standard therapy
Biological/vaccine: Belimumab 10 mg/kg plus standard therapy
Other: Standard therapy
Enrollment:
4019
Observational study model:
Not applicable
Primary completion date:
2018-30-07
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
Location
GSK Investigational Site
Beckley, West Virginia, United States, 25801
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35216
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1425AGC
Status
Study Complete
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Cedar Rapids, Iowa, United States, 52403
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
Summerville, South Carolina, United States, 29486
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1035
Status
Study Complete
Location
GSK Investigational Site
Clarksburg, West Virginia, United States, 26301
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Covina, California, United States, 91722
Status
Study Complete
Location
GSK Investigational Site
Cuautitlan Izcalli, Estado de México, Mexico, 54769
Status
Study Complete
Location
GSK Investigational Site
Cuiaba, Mato Grosso, Brazil, 78.040-360
Status
Study Complete
Location
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Status
Study Complete
Location
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2605
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85304
Status
Study Complete
Location
GSK Investigational Site
Gueishan Township,Taoyuan County, Taiwan, 333
Status
Study Complete
Location
GSK Investigational Site
Hialeah, Florida, United States, 33012
Status
Study Complete
Location
GSK Investigational Site
Hixson, Tennessee, United States, 37343-7908
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92646
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35801
Status
Study Complete
Location
GSK Investigational Site
Itajaí, Santa Catarina, Brazil, 88301-220
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39216
Status
Study Complete
Location
GSK Investigational Site
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Status
Study Complete
Location
GSK Investigational Site
Kalispell, Montana, United States, 59901
Status
Study Complete
Location
GSK Investigational Site
La Mesa, California, United States, 92020
Status
Study Complete
Location
GSK Investigational Site
La Plata, Buenos Aires, Argentina, 1900
Status
Study Complete
Location
GSK Investigational Site
Lanús, Buenos Aires, Argentina, B1824KAJ
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89128
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Study Complete
Location
GSK Investigational Site
Murrieta, California, United States, 92563
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85037
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90560-030
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 22411-001
Status
Study Complete
Location
GSK Investigational Site
Rock Hill, South Carolina, United States, 29732
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000BIF
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2002KDS
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95816
Status
Study Complete
Location
GSK Investigational Site
San Leandro, California, United States, 94578
Status
Study Complete
Location
GSK Investigational Site
San Luis Potosí, San Luis Potosí, Mexico, 78240
Status
Study Complete
Location
GSK Investigational Site
Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04032-060
Status
Study Complete
Location
GSK Investigational Site
Sao Paulo, São Paulo, Brazil, 01244-030
Status
Study Complete
Location
GSK Investigational Site
Seremban, Negeri Sembilan, Malaysia, 70300
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
St. Clair Shores, Michigan, United States, 48081
Status
Study Complete
Location
GSK Investigational Site
Sydney, New South Wales, Australia, 2153
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 01323-020
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucumán, Tucumán, Argentina, T4000BRD
Status
Study Complete
Location
GSK Investigational Site
Venado Tuerto, Santa Fe, Argentina, 2600
Status
Study Complete
Location
GSK Investigational Site
West Bloomfield, Michigan, United States, 48322
Status
Study Complete
Location
GSK Investigational Site
Wyomissing, Pennsylvania, United States, 19610
Status
Study Complete
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
Completed
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website