Actively Recruiting
Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis
Led by R-Pharm International, LLC · Updated on 2026-04-08
71
Participants Needed
14
Research Sites
376 weeks
Total Duration
On this page
Sponsors
R
R-Pharm International, LLC
Lead Sponsor
R
R-Pharm
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 612 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 6145 kg (cohort 1 - subgroup A) or 6130 and <45 kg (cohort 1 - subgroup B) or 6118 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) 613 months before screening, or
- Systemic JIA (sJIA) for 613 months before screening, provided that joint symptoms persist without active systemic manifestations for 613 months before screening, or
- Extended oligoarticular JIA (3eJIA) 613 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, 616 mg/l
- Intolerance or failure of methotrexate in the dose of 6115 mg/m^2/week (or less, in a case of documented intolerance of higher doses) for 613 months in medical history
You will not qualify if you...
- 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 doses above 0.2 mg/kg or 10 mg/day of prednisolone daily, whichever 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
- Change in dose of a non-steroidal anti-inflammatory drug (NSAID) within 642 weeks prior to Day 0
- Vaccination with live vaccines within 6 weeks before baseline, or planned vaccination with live vaccines during the study and/or within 6 weeks after the last olokizumab administration
- Active uveitis at screening or uveitis exacerbation within 24 weeks before screening
- Laboratory abnormalities: creatinine 651 mg/dL for children aged 12 or 651.2 mg/dL for children aged 13 and older; ALT or AST 651.5 x upper limit normal; platelets <180,000/mm^3; white blood count <4000/mm^3; neutrophils <2000/mm^3; hemoglobin 6148 g/L
- Exclusion criteria related to past or current infection other than tuberculosis
- Suspected or confirmed current tuberculosis (TB) infection, history of an active or latent TB infection
- Active disease associated with intestinal diverticula, history of diverticulitis or perforation, or concurrent Crohn's disease or ulcerative colitis
- Concurrent heart failure New York Heart Association (NYHA) III or IV functional class
- In patients with diabetes mellitus - HbA1c > 7% within the last 3 months (non-controlled diabetes mellitus)
- Patients with Steinbrocker class IV functional impairment
- Presence of systemic autoimmune or autoinflammatory disease, except JIA, or chronic autoimmune hepatitis or diseases of the primary immunodeficiencies group
- Patients with history of macrophage activation syndrome episodes
- Exclusion criteria related to concurrent diseases and conditions increasing potential risk related to study participation and drug exposure
- Known hypersensitivity to any component of the study drug
- Pregnant or breast-feeding female participants or planned pregnancy
- Other protocol-defined non-inclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation
Kazan', Russia, 420012
Actively Recruiting
2
Federal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology"
Moscow, Russia, 115522
Actively Recruiting
3
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, 119049
Actively Recruiting
4
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, 119435
Actively Recruiting
5
Federal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation
Moscow, Russia, 119991
Actively Recruiting
6
Limited Liability Company "Healthy Family Medical Center"
Novosibirsk, Russia, 630099
Actively Recruiting
7
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, 344022
Actively Recruiting
8
LLC "Medical Technologies"
Saint Petersburg, Russia, 192148
Actively Recruiting
9
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, 410054
Actively Recruiting
10
Limited Liability Company "Scientific Medical Center of General Therapy and Pharmacology" (LLC "TERAPHARM")
Stavropol, Russia, 55000
Actively Recruiting
11
State Budgetary Healthcare Institution of the Samara Region "Tolyatti City Clinical Hospital No. 5"
Tolyatti, Russia, 445039
Actively Recruiting
12
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Ufa, Russia, 450083
Actively Recruiting
13
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, 394036
Actively Recruiting
14
State Budgetary Institution of Healthcare of the Yaroslavl Region "Regional Children's Clinical Hospital"
Yaroslavl, Russia, 150000
Actively Recruiting
Research Team
A
Anna Karpenko
CONTACT
D
Darya Bukhanova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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