Belimumab Assessment of Safety in SLE (BASE)

• Register: EUCTR
• Last refreshed on: 8 August 2022
• Main ID: EUCTR2011-005667-25-PL
• Date of registration: 07/06/2013
• Prospective Registration: Yes
• Primary sponsor: Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)
• Public title: Belimumab Assessment of Safety in SLE (BASE)
• 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
• Date of first enrolment: 22/05/2014
• Target sample size: 4000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005667-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States

Contacts

• Name: Clinical Trials Helpdesk
• Affiliation: GlaxoSmithKline Research & Development Ltd

• Name: Clinical Trials Helpdesk
• Affiliation: GlaxoSmithKline Research & Development Ltd

Key inclusion & 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

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.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Lupus Erythematosus
MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: BELIMUMAB
CAS Number: 356547-88-1
Other descriptive name: Benlysta
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: The objectives of this study are to evaluate the following in adult SLE subjects receiving belimumab plus standard therapy versus subjects receiving placebo plus standard therapy:
• Mortality and adverse events of special interest over 1 year (through 52 weeks).
• Corticosteroid reduction during Weeks 40-52.

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: Timepoints
1) Incidence of all-cause mortality -Up to 52 weeks
2) Incidence of adverse events of special interest -Up to 52 weeks

Primary end point(s): Primary Endpoints:
1) Incidence of all-cause mortality
2) Incidence of adverse events of special interest. Summary of the number and percentage of participants with adverse events within 8 prespecified categories: serious infections, non-serious opportunistic infections and other infections of interest, malignancies (excluding non-melanoma skin cancers), non-melanoma skin cancers, psychiatric events, suicidality, serious infusion and hypersensitivity reactions, and all serious adverse events.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Timepoint: Baseline, weeks 40 to 52.

Secondary end point(s): Reduction in prednisone dose.
Percent 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 receiving greater than 7.5 mg/day at baseline.

Secondary ID(s)

HGS1006-C1113

NCT01705977

2011-005667-25-HU

Source(s) of Monetary Support

GlaxoSmithKline Research & Development Ltd

Human Genome Sciences Inc

Ethics review

Status: Approved
Approval date: 22/05/2014
Contact:

Results

• Results available: Yes
• Date Posted: 04/08/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005667-25/results