MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Benlysta
Product Name: Belimumab Solution for injection (200 mg/ml)
Product Code: NA
Pharmaceutical Form: Solution for injection
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1.Between 5 and 17 years of age inclusive, at the time of informed consent.2. Chinese paediatric participants with SLE, who have completed 48weeks treatment in study 213560 and who, in the opinion of the investigator, may benefit from treatment with GSK1550188.3.Body weight =15kg, at the time of signing the informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 16 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1.Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an AE in 213560 study that could, in the opinion of the principal investigator, put the participant at undue risk. 2. Have developed any other medical diseases (e.g., cardiopulmonary),laboratory abnormalities, or conditions that, in the opinion of the principal investigator, makes the participant unsuitable for the study. 3. Have an estimated glomerular filtration rate as calculated by Schwartz Formula of less than 30 mL/min. 4. Have an IgA deficiency (IgA level <10 mg/dL). 5. Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale (Section 10.2.1) except for the following that are allowed: a) Stable Grade 3 hypoalbuminemia due to lupus nephritis and not related to liver disease or malnutrition. b) Any grade proteinuria c) Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis and not related to alcoholic liver disease, uncontrolled diabetes or viral hepatitis. If present, any abnormalities in the alanine transaminase (ALT)and/or aspartate aminotransferase (AST) must be = Grade 2. d) Stable Grade 3 neutropenia; or stable Grade 3 lymphopenia; or stable Grade 3 leukopenia, due to SLE Diagnostic Assessments. 6.Have received a live or live-attenuated vaccine within 30 days of Day Other Exclusions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize belimumab exposure following belimumab 200 mg SC in Chinese paediatric systemic lupus erythematosus (SLE) participants who have previously been treated with IV belimumab.;Secondary Objective: To evaluate the safety and tolerability of belimumab 200mg SC in paediatric Participants with SLE who have previously been treated with IV belimumab;Primary end point(s): Belimumab exposure parameters: AUCss, 0-t, Cavg,ss, Cmin,ss, Cmax,ss;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of adverse events, serious adverse events and adverse events of special interest through Week12;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
China
Contacts
Public ContactHafsa Khan
GlaxoSmithKline Research & Development Limited
Outcome results
None listed