An Open-label, Multicenter Study of the Pharmacokinetics, Efficacy and Safety of Olokizumab in Pediatric and Adolescent Patients With Active Juvenile Idiopathic Arthritis
The primary objective of this study is to evaluate the pharmacokinetics (PK) of olokizumab (OKZ) in patients with polyarticular juvenile idiopathic arthritis aged \>2 and \<18 years in two doses (64 mg or 48 mg every 4 weeks) depending on patient's weight. Secondary objectives are to evaluate the pharmacodynamic (PD) profile, the long-term efficacy and safety of olokizumab in patients with polyarticular juvenile idiopathic arthritis aged \>2 and \<18 years.
• Study informed consent form voluntarily and independently signed by patient legal representative
• Study assent form voluntarily and independently signed by minor study subject (patient)
• Male or female patients aged ≥12 and \<18 years (cohort 1 - subgroup A) or \>2 and \<12 years (cohort 1 - subgroup B) or \>2 and \<18 years (cohort 2) at the time of screening initiation and on Day 0
• Body weight at the start of screening and on Day 0 ≥45 kg (cohort 1 - subgroup A) or ≥30 and \<45 kg (cohort 1 - subgroup B) or ≥18 and \<30 kg (cohort 2)
• A reliable diagnosis of juvenile idiopathic arthritis (JIA) according to the JIA International League of Associations for Rheumatology (ILAR) 1 criteria with onset before the age of 16 years:
‣ Seropositive or seronegative polyarthritis (pJIA) ≥3 months before screening, or
⁃ Systemic JIA (sJIA) for ≥3 months before screening, provided that joint symptoms persist without active systemic manifestations for ≥3 months before screening, or
⁃ Extended oligoarticular JIA (оJIA) ≥3 months before screening
• American College of Radiology (ACR) criteria of active polyarthritis are met: 5 or more active joints at screening and on Day 0
• C-reactive protein (CRP) level on screening or in anamnesis, not associated with alternative causes of increase other than the activity of the underlying disease, ≥6 mg/l
• Intolerance or failure of methotrexate in the dose of ≥15 mg/m\^2/week (or less, in a case of documented intolerance of higher doses) for ≥3 months in medical history