Juvenile idiopathic arthritis MedDRA version: 21.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SARILUMAB
Curr
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female patients aged =2 and =17 years (or country specified age requirement) at the time of the screening visit. -Diagnosis of rheumatoid factor-negative or rheumatoid factor positive polyarticular Juvenile Idiopathic Arhtritis (JIA) subtype or oligoarticular extended JIA subtype according to the International League of Associations for Rheumatology (ILAR) 2001 Juvenile Idiopathic Arthritis Classification Criteria with at least 5 active joints as per American College of Rheumatology (ACR) definition for “active arthritis” at screening. -Patient with an inadequate response to current treatment and considered as a candidate for a biologic disease-modifying antirheumatic drug (DMARD) as per Investigator’s judgment. Are the trial subjects under 18? yes Number of subjects for this age range: 100 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: -Body weight 60 kg for patients enrolled in the 3 ascending dose cohorts, then body weight <10 kg for patients subsequently enrolled at the selected dose-regimen. -If nonsteroidal anti-inflammatory drugs (NSAIDs, including cyclo-oxygenase-2 inhibitors [COX-2]) taken, dose stable for less than 2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label. -If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling. -If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 0.5 mg/kg/day (or 30 mg/day) within 2 weeks prior to baseline. -Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline. -Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab. -Treatment with any biologic DMARD within 5 half-lives prior to the first dose of sarilumab -Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements). -Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer. -Lipid lowering drug stable for less than 6 weeks prior to screening. -Exclusion related to tuberculosis (TB). -Exclusion criteria related to past or current infection other than tuberculosis. -Any live, attenuated vaccine within 4 weeks prior to the baseline, such as varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be permitted based on the Investigator's judgment. -Exclusion related to history of a systemic hypersensitivity reaction to any biologic drug and known hypersensitivity to any constituent of the product. -Laboratory abnormalities at the screening visit (identified by the central laboratory). Pregnant or breast-feeding female adolescent patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 2 - 17 years with Polyarticular-course Juvenile idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for continued development in this population.;Secondary Objective: To describe the pharmacodynamics (PD) profile, the efficacy and the long term safety of sarilumab in patients with pcJIA.; Primary end point(s): Assessment of PK parameter: maximum serum concentration observed (Cmax) Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t) Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough) ;Timepoint(s) of evaluation of this end point: Up to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Number of adverse events 2- Acceptability assessments (local tolerability) 3- Juvenile Idiopathic Arthritis (JIA ACR) 30/ 50/ 70/ 90/ 100 response rate 4- Change from baseline in JIA ACR Component: Physician's global assessment of disease activity 5- Change from baseline in JIA ACR Component: Patient / parent assessment of overall well-being 6- Change from baseline in JIA ACR Component: Childhood Health Assessment Questionnaire (CHAQ) - Disability Index 7- Change from baseline in JIA ACR Component: Number of joints with active arthritis 8- Change from baseline in JIA ACR Component: Number of joints with limitation of motion 9- Change from baseline in JIA ACR Component: High sensitivity C-reactive protein (hs-CRP) 10- Juvenile Arthritis Disease Activity Score-27 (JADAS) change from baseline 11- Changes in IL-6 associated biomarkers 12- Changes in IL-6 associated biomarkers: sIL-6R ; Timepoint(s) of evaluation of this end point: 1 : Core treatment phase: Up to Week 12 - Extension phase: Up to end of study (Week 162 for dose-finding and second portions or W102 for third portion) 2 : Core treatment phase: Up to Week 12 - Extension phase: Up to end of treatment (Week 156 for dose-finding and second portions or W96 for third portion) 3-10 : Core treatment phase: Up to Week 12 - Extension phase: up to W156 for dose-finding and second portions or W96 for third portion 11-12 : Up to week 12 | — |
Countries
Argentina, Canada, Chile, Czech Republic, Estonia, Finland, France, Germany, Italy, Mexico, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactMedical Information
sanofi-aventis recherche & développement
Outcome results
None listed