Juvenile Idiopathic Arthritis MedDRA version: 19.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female patients aged =1 and =17 years at the time of the screening visit. -Diagnosis of systemic Juvenile Idiopathic Arthritis (JIA) subtype according to the International Associations against Rheumatism (ILAR) 2001 Juvenile Idiopathic Arthritis Classification Criteria with the following features at screening: -=5 active joints at screening or; -=2 active joints at screening with systemic JIA fever >37.5 °C in the 3 days preceding baseline or for at least 3 out of any 7 consecutive days during screening despite glucocorticoids at a stable dose for at least 3 days. -Patients 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: 36 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. -Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome within 6 months prior to screening. -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 1 mg/kg/day (or 60 mg/day) within 3 days 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. -Treatment with any Investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer. -Active tuberculosis patients or latent tuberculosis patients without adquate treatment. -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients with sJIA in order to identify the dose and regimen for continued development in this population.;Secondary Objective: To describe: -The pharmacodynamic (PD) profile, the efficacy and the safety of sarilumab in patients with sJIA. -The long term safety of sarilumab in patients with sJIA.;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 patients with adverse events 2- Number of patients with local site reactions 3- Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) response rate 4- Change from baseline in individual JIA ACR components 5- Changes in IL-6 associated biomarkers 6- Number of patients with adverse events 7- Number of patients with local site reactions 8- Change from baseline in individual JIA ACR components;Timepoint(s) of evaluation of this end point: 1-5: Up to week 12 6-8: Up to week 104 | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, Czech Republic, Estonia, Finland, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public Contactservizio contract point
sanofi S.p.A.
Outcome results
None listed