An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase
- Conditions
- arthritis in childrenpoly articular juvenile idiopathic arthritis1002142910003816
- Registration Number
- NL-OMON46846
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
Patients need to fulfill all inclusion criteria mentioned below:;1) -Male and female patients aged >=2 and <=17 years at the time of the screening visit.;2) -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.;3) -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.
-Body weight <10 kg or >60 kg.
-If non-steroidal anti-inflammatory drugs 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.
-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.
-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;-Wheelchair-bound or bed ridden
- Diagnosis of JIA subtypes except polyarticular RF positive (RF+) or RF negative (RF ) JIA or extended oJIA
-Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to Baseline
-Lipid-lowering drug stable for less than 6 weeks prior to screening.
-Exclusion related to tuberculosis (TB)
-Prior or current history of malignancy
-Prior or current history of other significant concomitant illness(es) that, according to the investigator*s judgment, would adversely affect the patient*s participation in the study.
-Patient with nonhealed/healing skin ulcers
-Surgery within 4 weeks prior to the screening visit or planned surgery during the course of the study.
- History of a systemic hypersensitivity reaction, other than localized injection site reaction, to any biologic drug and known hypersensitivity to any constituent of the product
-History of inflammatory bowel disease, severe diverticulitis, or previous gastrointestinal perforation whatever the cause
-Uncontrolled diabetes mellitus, defined as glycosylated hemoglobin (HbA1c) >=9% at the Screening visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Assessment of PK parameter: maximum serum concentration observed (Cmax)<br /><br>Assessment of PK parameter: Area under the serum concentration versus time<br /><br>curve calculated using the trapezoidal method during a dose interval (AUC0-t)<br /><br>Assessment of PK parameter: Concentration observed before treatment<br /><br>administration during repeated dosing (Ctrough)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Number of patients with adverse events<br /><br>Number of patients with local site reactions<br /><br>Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30)<br /><br>response rate<br /><br>Change from baseline in individual JIA ACR components<br /><br>Changes in IL-6 associated biomarkers</p><br>