Lupus Erythematosus MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
GlaxoSmithKline, LLC
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 | — |
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, Czechia, 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
Outcome results
None listed