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)
Prior use of any drug that acts directly on IL-6 or IL-6R
If methotrexate is administered - any change in dose or in a formulation within 6 weeks prior to Day 0
Previous therapy with marketed or experimental conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic disease-modifying anti-rheumatic drugs (bDMARDs) within less than 5 elimination half-lives
Use of oral steroids in the doses above 0.2 mg/kg or 10 mg/day of prednisolone daily, whatever is lower, or a change in dose within 2 weeks prior to Day 0, or use of parenteral or topical steroids within 4 weeks prior to Day 0
R-Pharm International, LLC
Lead sponsor
R-Pharm
Collaborator
Keystat, LLC
Collaborator
Exacte Labs LLC
Collaborator