Belimumab Assessment of Safety in SLE (BASE)

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005667-25-EE

Enrollment

4000

Registered

2012-12-12

Start date

2013-01-08

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Erythematosus MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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;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. ;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	—

Measure

Time frame

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;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. ;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

—

Secondary

Measure	Time frame
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.;Timepoint(s) of evaluation of this end point: Timepoint: Baseline, weeks 40 to 52.	—

Countries

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

Public ContactClinical Trials Helpdesk

GlaxoSmithKline Research & Development Ltd

GSKClinicalSupportHD@gsk.com0044208 990 4466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026