arthritis in children systemic juvenile idiopathic arthritis
Conditions
Interventions
Juvenile arthritis
sarilumab
Participants will receive one of three ascending doses of sarilumab trough
subcutaneous injection based on body weight
-Group A (above 30 kg and below 60 kg) or
-Group B { below 30 kg and above 10 kg)] weekly or biweekly injections
children
Sponsors
Sanofi-aventis
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1) Male and female patients aged >=1 and =5 active joints at screening or; ->=2 active joints at screening with systemic JIA fever bigger as 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. 3) Patients with an inadequate response to current treatment and considered as a candidate for a biologic disease-modifying anti-rheumatic drug (DMARD) as per Investigator*s judgment.
Exclusion criteria
Exclusion criteria: -Body weight below 10 kg or more than 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. -Use of parenteral intra-articular injection of glucocorticoid within 4 weeks prior baseline. -Lipid-lowering drug stable for less than 6 weeks prior to screening. -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 treatment for sJIA 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. -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 Investigators judgment. -Severe cardiac disease due to sJIA. -History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary alveolar proteinosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 (AUCO-t) Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients witha dverse events Number of patients with local site reactions Juvenile ldiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) response rate Change from baseline in individual JIA ACR components Changes in IL-6 associated biomarkers | — |
Countries
Argentina, Canada, Chile, Czechia, Estonia, Finland, France, Germany, Italy, Mexico, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States of America
Outcome results
None listed