A Phase 2 interventional study of OKZ q4w and OKZ q4w in Juvenile Idiopathic Arthritis, sponsored by R-Pharm International, LLC. Recruiting at 14 sites in Russia. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by R-Pharm International, LLC (part of R-Pharm) · Phase 2, Interventional, and Treatment
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:
The total study duration for patients is approximately 188 weeks (including the screening period).
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
This study's planned enrollment of 71 is above the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →R-Pharm International, LLC is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SC injections q4w-Cohort 1
Drug: OKZ q4w
SC injections q4w-Cohort 2
Drug: OKZ q4w
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
Treatment response, based on Juvenile idiopathic Arthritis American College of Rheumatology (JIA ACR) 30, 50, 70 and 90 criteria over the study period
* JIA ACR 30 responder is defined as a participant with at least 3 out of the 6 JIA core set variables with ≥ 30% improvement from baseline with no more than 1 of the remaining variables worsened by ≥ 30% * JIA ACR 50 responder is defined as a participant with at least 3 out of the 6 JIA core set variables with ≥ 50% improvement from baseline with no more than 1 of the remaining variables worsened by ≥ 30% * JIA ACR 70 responder is defined as a participant with at least 3 out of the 6 JIA core set variables with ≥ 70% improvement from baseline with no more than 1 of the remaining variables worsened by ≥ 30% * JIA ACR 90 responder is defined as a participant with at least 3 out of the 6 JIA core set variables with ≥ 90% improvement from baseline with no more than 1 of the remaining variables worsened by ≥ 30%
Time frame: 24, 72, 164 weeks
Changes in Juvenile Arthritis Disease Activity Score-10 (JADAS-10) over the study period
The JADAS-10 includes 4 measures: 1. physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity) 2. parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and 10= maximum activity) 3. count of active joints (range: 0 to 10; where 0= no activity and 10= maximum activity) 4. index of inflammation determined by high-sensitivity C-reactive protein (hs-CRP) or erythrocyte sedimentation rate (ESR) (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity)
Time frame: 24, 72, 164 weeks
Changes in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) over the study period
The JADAS-27 includes 4 measures: 1. physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity) 2. parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and 10= maximum activity) 3. count of active joints (range: 0 to 27; where 0= no activity and 27= maximum activity) 4. index of inflammation determined by high-sensitivity C-reactive protein (hs-CRP) or erythrocyte sedimentation rate (ESR) (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity)
Time frame: 24, 72, 164 weeks
Changes in Juvenile Arthritis Disease Activity Score-71 (JADAS-71) over the study period
The JADAS-71 includes 4 measures: 1. physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity) 2. parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and 10= maximum activity) 3. count of active joints (range: 0 to 71; where 0= no activity and 71= maximum activity) 4. index of inflammation determined by high-sensitivity C-reactive protein (hs-CRP) or erythrocyte sedimentation rate (ESR) (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity)
Time frame: 24, 72, 164 weeks
Proportion of patients with minimal disease activity/inactive disease according to Juvenile Arthritis Disease Activity Score (JADAS) criteria
JADAS inactive disease is defined by a JADAS-27 score less than or equal to 1 The JADAS-27 includes 4 measures: 1. physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity) 2. parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and 10= maximum activity) 3. count of active joints (range: 0 to 27; where 0= no activity and 27= maximum activity) 4. index of inflammation determined by high-sensitivity C-reactive protein (hs-CRP) or erythrocyte sedimentation rate (ESR) (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity)
Time frame: 24, 72, 164 weeks
Changes in physician assessments of disease activity (VAS) over the study period
Physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity). Higher scores indicate better outcome
Time frame: 24, 72,164 weeks
Changes in patient/parent assessments of disease activity (VAS) over the study period
Parent/patient global assessment of well-being (VAS range: 0 to 10; where 0= no activity and 10= maximum activity). Higher scores indicate better outcome
Time frame: 24, 72, 164 weeks
Changes in the number of active joints over the study period
Active joint is defined as defined as a swollen joint or, in the absence of swelling, with limited mobility accompanied by pain/tenderness
Time frame: 24, 72, 164 weeks
Changes in the number of joints with functional limitations over the study period
Functional limitations is defined as defined as a swollen joint or, in the absence of swelling, with limited mobility accompanied by pain/tenderness
Time frame: 24, 72, 164 weeks
Changes in the Childhood Health Assessment Questionnaire (CHAQ) disability index (DI) over the study period
The CHAQ questionnaire consists of 30 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain is scored on a 4 point scale ranges from 0 to 3: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). An additional response of "not applicable" is available to indicate activities the participant is unable to perform because he/she is too young. The CHAQ-DI total score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (the worst). Higher scores indicate worse outcome
Time frame: 24, 72, 164 weeks
Changes in blood C-reactive Protein (CRP) concentrations over the study period
Serum concentrations of CRP is determined to assess the Pharmacodynamic (PD) effects of olokizumab
Time frame: 24, 72, 164 weeks
Proportion of patients with clinically inactive disease during the study according to American College of Rheumatology (ACR) criteria
Clinically inactive disease is defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy associated with JIA; absence of active uveitis; normal erythrocyte sedimentation rate (ESR) and/or C-reactive Protein (CRP); absence of disease activity according to the physician's global assessment of disease activity (VAS) scale; morning stiffness less than 15 minutes
Time frame: 24, 72, 164 weeks
Proportion of patients with pharmacologic remission during the study according to American College of Rheumatology (ACR) criteria
Pharmacologic remission is defined as a clinically inactive disease for at least 6 months. Clinically inactive disease is defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy associated with JIA; absence of active uveitis; normal erythrocyte sedimentation rate (ESR) and/or C-reactive Protein (CRP); absence of disease activity according to the physician's global assessment of disease activity (VAS) scale; morning stiffness less than 15 minutes
Time frame: 24, 72, 164 weeks
Proportion of patients with exacerbation of Juvenile Idiopathic Arthritis (JIA) according to Pediatric Rheumatology Collaborative Study Group (PRCSG)-Paediatric Rheumatology International Trials Organisation (PRINTO) criteria
Proportion of patients with exacerbation of JIA according to PRCSG-PRINTO criteria during the first 24 weeks of the study and the entire study Juvenile Idiopathic Arthritis (JIA) exacerbation is defined as a deterioration of 30% or more in 3 or more of the 6 JIAcore components, with an improvement of no more than 1 item by 30% or more JIAcore components include: * Number of joints with active arthritis (defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by pain/tenderness) * Number of joints with limitation of motion * Physician Global Assessment of Disease Activity (VAS 100 mm) * Parent/Patient Global Assessment of Overall Well-being (VAS 100 mm) * Physical function (Childhood Health Assessment Questionnaire - CHAQ) * Erythrocyte Sedimentation Rate / C-reactive Protein (ESR/CRP)
Time frame: 24, 72, 164 weeks
Character of adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs)
Adverse events of special interest include: * Infections (particularly serious infections), including tuberculosis (TB) and opportunistic infections * Malignancies * Elevations in blood lipid levels * Systemic injection-related reactions and hypersensitivity reactions, including anaphylaxis * Gastrointestinal perforation * Cardiovascular complications * Neutropenia, thrombocytopenia, leukopenia, and pancytopenia * Hepatotoxicity * Injection site reactions * Demyelinating events involving the peripheral or central nervous system
Time frame: 168, 172, 186 weeks
Frequency of adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs)
Adverse events of special interest include: * Infections (particularly serious infections), including tuberculosis (TB) and opportunistic infections * Malignancies * Elevations in blood lipid levels * Systemic injection-related reactions and hypersensitivity reactions, including anaphylaxis * Gastrointestinal perforation * Cardiovascular complications * Neutropenia, thrombocytopenia, leukopenia, and pancytopenia * Hepatotoxicity * Injection site reactions * Demyelinating events involving the peripheral or central nervous system
Time frame: 168, 172, 186 weeks
Severity of adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs)
Adverse events of special interest include: * Infections (particularly serious infections), including tuberculosis (TB) and opportunistic infections * Malignancies * Elevations in blood lipid levels * Systemic injection-related reactions and hypersensitivity reactions, including anaphylaxis * Gastrointestinal perforation * Cardiovascular complications * Neutropenia, thrombocytopenia, leukopenia, and pancytopenia * Hepatotoxicity * Injection site reactions * Demyelinating events involving the peripheral or central nervous system
Time frame: 168, 172, 186 weeks
Outcomes of adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs)
Adverse events of special interest include: * Infections (particularly serious infections), including tuberculosis (TB) and opportunistic infections * Malignancies * Elevations in blood lipid levels * Systemic injection-related reactions and hypersensitivity reactions, including anaphylaxis * Gastrointestinal perforation * Cardiovascular complications * Neutropenia, thrombocytopenia, leukopenia, and pancytopenia * Hepatotoxicity * Injection site reactions * Demyelinating events involving the peripheral or central nervous system
Time frame: 168, 172, 186 weeks
Proportion of participants with adverse events (AEs)
Proportion of participants with AEs
Time frame: 168, 172, 186 weeks
Proportion of participants with serious adverse events (SAEs)
Proportion of participants with SAEs
Time frame: 168, 172, 186 weeks
Proportion of participants with clinically significant abnormalities in laboratory test results
Proportion of participants with clinically significant abnormalities in laboratory test results
Time frame: 168, 172, 186 weeks
Number of Participants With Laboratory Abnormalities
Laboratory parameters include: * Hematology * Blood Biochemistry test * Interferon-gamma release assay * Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus tests * Coagulogram * Lipid profile blood test * Blood test for inflammatory markers * Blood test for antinuclear factor, rheumatoid factor, and anti-dsDNA antibodies * Complete Urinalysis * Pharmacokinetics (PK) analysis (Drug concentration) * Blood test for anti-drug antibodies (ADA) and neutralizing antibodies (nAb) * Blood test for cytokine levels (IL-6, IL-6R) * HLA-B27 genetic blood test / HLA-B27 genotyping
Time frame: 168, 172, 186 weeks
Number of Participants With Vital Sign Abnormalities
Vital Signs include: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature. Abnormality in vital signs is based on investigator's discretion
Time frame: 168, 172, 186 weeks
Number of Participants With Physical Examination Abnormalities
Physical examination included: skin, heart, lungs, abdomen, liver, spleen, ENT organs, lymph nodes. Abnormality in physical examination is based on investigator's discretion
Time frame: 168, 172, 186 weeks
Proportion of participants who developed anti-drug antibodies (ADA) to the investigational product during the study and overall
Proportion of participants who developed anti-drug antibodies (ADA) to the investigational product during the study and overall
Time frame: 168, 172, 186 weeks
Proportion of participants who developed neutralizing antibodies (nAb) to the investigational product during the study and overall
Proportion of participants who developed neutralizing antibodies (nAb) to the investigational product during the study and overall
Time frame: 168, 172, 186 weeks
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Studies of the drug tested here: Olokizumab