Testing Sarilumab SAR153191 for juvenile idiopathic arthritis

Exclusion

• −ExclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → related to history of a systemic hypersensitivity reaction to any biologic drug and known hypersensitivity to any constituent of the product.
• −Body weight \<10 kg or \>60 kg for patients enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in the ascending dose cohortsCohortA group of participants sharing a characteristic, followed together.Read more →, then body weight \<10 kg for patients subsequently enrolled at the selected dose.
• −Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome (MAS) within 6 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• −History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary alveolar proteinosis.
• −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 visitBaselineYour starting measurements, taken before treatment begins.Read more → 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 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 treatment for sJIA within 5 half-lives prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
• −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.
• −Exclusion related to tuberculosis.
• −Exclusion criteria related to past or current infection other than tuberculosis.
• −Any live, attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be permitted based on the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgment.
• −Laboratory abnormalities at the screening visit (identified by the central laboratory).
• −Severe cardiac disease due to sJIA.
• −The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
• −Pregnant or breast-feeding female adolescent patients.