Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis

Recruiting Phase 2 Interventional Study
Juvenile Idiopathic Arthritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
71 (estimated)
Sponsor
R-Pharm International, LLC · Industry
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About This Trial
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 polyart…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Study informed consent form voluntarily and independently signed by patient legal representative 2. Study assent form voluntarily and independently signed by minor study subject (patient) 3. Male or female patients aged ≥12 and \<18 years (cohort 1 - subgroup A) or \>2 and \<…
Contacts

Anna Karpenko

+7 (495) 956-79-37

karpenko@rpharm.ru

CONTACT

Darya Bukhanova

+7 (495) 956-79-37

bukhanova@rpharm.ru

CONTACT