Clinical Research Directory
Browse clinical research sites, groups, and studies.
Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis
Sponsor: R-Pharm International, LLC
Summary
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.
Official title: An Open-label, Multicenter Study of the Pharmacokinetics, Efficacy and Safety of Olokizumab in Pediatric and Adolescent Patients With Active Juvenile Idiopathic Arthritis
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2023-03-17
Completion Date
2030-06
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
OKZ q4w
Subcutaneous (SC) injections of OKZ every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection
OKZ q4w
SC injections of OKZ 48 mg every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection
Locations (14)
Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation
Kazan', Russia
Federal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology"
Moscow, Russia
State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's City Clinical Hospital of the Moscow City Health Department" (GBUZ "Morozovskaya DGBK DZM")
Moscow, Russia
Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation (Sechenov University)
Moscow, Russia
Federal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation
Moscow, Russia
Limited Liability Company "Healthy Family Medical Center"
Novosibirsk, Russia
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
Rostov-on-Don, Russia
LLC "Medical Technologies"
Saint Petersburg, Russia
Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation
Saratov, Russia
Limited Liability Company "Scientific Medical Center of General Therapy and Pharmacology" (LLC "TERAPHARM")
Stavropol, Russia
State Budgetary Healthcare Institution of the Samara Region "Tolyatti City Clinical Hospital No. 5"
Tolyatti, Russia
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Ufa, Russia
Federal State Budgetary Educational Institution of Higher Education "Voronezh State Medical University named after N.N. Burdenko" of the Ministry of Health of the Russian Federation
Voronezh, Russia
State Budgetary Institution of Healthcare of the Yaroslavl Region "Regional Children's Clinical Hospital"
Yaroslavl, Russia