Systemic Lupus Erythematosus
Conditions
Interventions
investigational material(s)
Generic name etc :
INN of investigational material : belimumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigat
Sponsors
GlaxoSmithKline K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participant must be between 5 and 17 years of age inclusive, at the time of Day 1. -Participants who meet the 1997 American College of Rheumatology (ACR) criteria for the classification of SLE. -Have active SLE disease defined as a safety of estrogen in lupus erythematosus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score >=6 at screening. -Have documented positive autoantibody test results within the study screening period. -Are on a stable SLE treatment regimen, "Stable treatment at Baseline" administered for a period of at least 30 days prior to Day 1; -Body weight >=15 kg. etc.
Exclusion criteria
Exclusion criteria: -Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 milliliter/minute (mL/min). -Have acute severe nephritis defined as significant renal disease . -Have clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE. -Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months, or who in the investigator's opinion, pose a significant suicide risk. -Have a history of a primary immunodeficiency. -Have an immunoglobulin A (IgA) deficiency. -Have acute or chronic infections requiring management. -Have ever received treatment with belimumab. -Have active central nervous system (CNS) lupus. -Have required renal replacement therapy. -Positive immunodeficiency virus (HIV) antibody test -Hepatitis B -Hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed belimumab concentrations at Week12 Estimated Cavg, Cmax and Cmin of belimumab at steady state | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) ,serious adverse events (SAEs) and adverse events of special interest (AESIs). Change from Baseline in biomarkers at Week 12 and 52. | — |
Countries
Argentina, Germany, Mexico, Netherlands, Spain, United States
Contacts
Public ContactYasutoshi Okawa
GlaxoSmithKline K.K.
Outcome results
None listed