Juvenile Idiopathic Arthritis (JIA) Clinical Trials

Find Juvenile Idiopathic Arthritis (JIA) Clinical Trials Near You

An Open-label, Multicenter Study of the Pharmacokinetics, Efficacy and Safety of Olokizumab in Pediatric and Adolescent Patients With Active Juvenile Idiopathic Arthritis

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Federal State Budgetary Educational Institution of Higher Education Kazan State Medical University of the Ministry of Health of the Russian Federation
RECRUITING
Kazan'
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)
RECRUITING
Moscow
Federal State Autonomous Institution National Medical Research Center for Children's Health of the Ministry of Health of the Russian Federation
RECRUITING
Moscow
Federal State Budgetary Scientific Institution V.A. Nasonova Research Institute of Rheumatology
RECRUITING
Moscow
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)
RECRUITING
Moscow
Limited Liability Company Healthy Family Medical Center
RECRUITING
Novosibirsk
Federal State Budgetary Educational Institution of Higher Education Rostov State Medical University of the Ministry of Health of the Russian Federation
RECRUITING
Rostov-on-don
LLC Medical Technologies
RECRUITING
Saint Petersburg
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
RECRUITING
Saratov
Limited Liability Company Scientific Medical Center of General Therapy and Pharmacology (LLC TERAPHARM)
RECRUITING
Stavropol
State Budgetary Healthcare Institution of the Samara Region Tolyatti City Clinical Hospital No. 5
RECRUITING
Tolyatti
Federal State Budgetary Educational Institution of Higher Education Bashkir State Medical University of the Ministry of Health of the Russian Federation
RECRUITING
Ufa
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
RECRUITING
Voronezh
State Budgetary Institution of Healthcare of the Yaroslavl Region Regional Children's Clinical Hospital
RECRUITING
Yaroslavl
Contact Information
Primary
Anna Karpenko
karpenko@rpharm.ru
+7 (495) 956-79-37
Backup
Darya Bukhanova
bukhanova@rpharm.ru
+7 (495) 956-79-37
Time Frame
Start Date: 2023-03-17
Estimated Completion Date: 2030-06
Participants
Target number of participants: 71
Treatments
Experimental: Arm 1: OKZ 64 mg q4w
SC injections q4w-Cohort 1
Experimental: Arm 2: OKZ 48 mg q4w
SC injections q4w-Cohort 2
Sponsors
Collaborators: Exacte Labs LLC, Keystat, LLC, R-Pharm
Leads: R-Pharm International, LLC

This content was sourced from clinicaltrials.gov

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