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.
This study is a multicenter, open-label, non-randomized, uncontrolled study with an interim analysis of endpoints after 12 weeks of therapy, a final analysis of endpoints after 24 weeks of therapy, and an additional analysis at the end of all study visits. The total number of study subjects screened is 71 subjects. Up to 50 patients will begin treatment. This study includes: 1. A screening period of up to 2 weeks 2. A main period of open label treatment from Week 0 to Week 24 (24 weeks) 3. A period of extended open label treatment from Week 24 to Week 164 (140 weeks) 4. Safety follow-up period from Week 165 to Week 186 (22 weeks) The total study duration for patients is approximately 188 weeks (including the screening period).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation
Kazan', Russia
RECRUITINGFederal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology"
Moscow, Russia
RECRUITINGState 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
RECRUITINGFederal 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
RECRUITINGFederal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation
Moscow, Russia
RECRUITINGLimited Liability Company "Healthy Family Medical Center"
Novosibirsk, Russia
RECRUITINGFederal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
Rostov-on-Don, Russia
RECRUITINGLLC "Medical Technologies"
Saint Petersburg, Russia
RECRUITINGFederal 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
RECRUITINGLimited Liability Company "Scientific Medical Center of General Therapy and Pharmacology" (LLC "TERAPHARM")
Stavropol, Russia
RECRUITING...and 4 more locations
Olokizumab Cmax (W24) (maximum concentration) over 24 weeks
The Cmax is defined as maximum serum concentration of olokizumab
Time frame: 24 weeks
Olokizumab area under the concentration-time curve (AUC0-W24) over 24 weeks
The AUC0-W24 is defined as area under the plasma concentration-time curve over the dosing interval (AUC0-W24)
Time frame: 24 weeks
Minimum drug concentration at steady state (Ctrough,ss)
The Ctrough is defined as concentration observed before treatment administration during repeated dosing at steady state
Time frame: 24 weeks
Maximum concentration (Cmax) of olokizumab after the first administration
The Cmax is defined as maximum serum concentration of olokizumab
Time frame: 4 weeks
Time to reach maximum concentration (tmax) of olokizumab after the first administration
T(max) is defined as the time it takes for a drug to reach the maximum concentration (Cmax) after administration of olokizumab
Time frame: 4 weeks
The area under the concentration-time curve (AUCtau) of olokizumab over the study period
The AUCtau is defined as area under the plasma concentration-time curve over the dosing interval (AUC0-tau)
Time frame: 12, 24, 72 weeks
Concentration before the next dose of olokizumab (Ctrough)
The Ctrough is defined as concentration observed before the next dose of olokizumab during repeated dosing
Time frame: 12, 24, 72 weeks
Time to steady state (tss)
Time to reach steady state will be assessed both graphically and statistically. The statistical approach will involve fitting a repeated measures linear mixed model to natural log-transformed data, using Helmert contrasts to compare earlier and later weeks, and identifying the earliest week where the mean concentration difference is not statistically significant
Time frame: 12, 24, 72 weeks
Area under the concentration-time curve in the steady state (AUCss)
The АUCss is defined as the area under the curve of the plasma concentration of the drug in the dosing interval at steady state
Time frame: 24, 72 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.