Tofacitinib for Juvenile idiopathic arthritis

Inclusion criteria

• {"criterion_text":"- Polyarticular course JIA"}
• {"criterion_text":"- Moderate or high-disease activity (cJADAS10 >5) despite treatment with an initial TNFi for greater than or equal to 3 months"}
• {"criterion_text":"- Age higher or equal to 2 years and <18 years and weight greater than or equal to 10 kg"}
• {"criterion_text":"- No systemic glucocorticoids or systemic glucocorticoids at a stable dose of less or equal to 0.2 mg/kg/day (maximum 10 mg/day) for more or equal to 2 weeks prior to baseline visit"}
• {"criterion_text":"- Documented informed consent/assent obtained from the parent/caregiver/patient"}
• {"criterion_text":"- Females of childbearing potential are eligible only if they agree to use the required contraception methods or are not sexually active"}

Exclusion criteria

• {"criterion_text":"- Systemic JIA"}
• {"criterion_text":"- Any active acute, subacute, chronic, or recurrent bacterial, viral (including HIV, HCV, and HBV), or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit. HBsAg positive and HBcAb negative: Participant is excluded from study. HBsAg negative and HBcAb positive and HBsAb negative: Participant is excluded from study. HCV Ab positive and HCV RNA positive: Participant is excluded from study (HCV RNA sample collection may be deferred and collected only if required to confirm eligibility in HCV Ab positive patients). HIV-1 or HIV-2 antibody positive: Participant is excluded from study."}
• {"criterion_text":"- Any medical history considered a contraindication/safety concern by the study investigator with the use of adalimumab, etanercept, tofacitinib, ABA, or an IL-6 inhibitor or their biosimilars. In particular, subjects at high risk for venous thromboembolism will be excluded. A subject may be at high risk for venous thromboembolism if they: - have heart failure or prior myocardial infarction within past 3 months; -have inherited coagulation disorders;-have had venous thromboembolism, either deep venous thrombosis or pulmonary embolism; -are undergoing major surgery or is immobilized."}
• {"criterion_text":"- Enthesitis-related arthritis/juvenile spondyloarthritis (2001 International League of Associations for Rheumatology [ILAR] criteria)"}
• {"criterion_text":"- Pregnant or breastfeeding"}
• {"criterion_text":"- History of or currently active inflammatory bowel disease"}
• {"criterion_text":"- History of or currently active psoriasis"}
• {"criterion_text":"- Active uveitis within 3 months of the baseline visit"}
• {"criterion_text":"- History of or currently active sacroiliitis"}
• {"criterion_text":"- History of or current malignancy"}
• {"criterion_text":"- Active tuberculosis (TB) or a history of incompletely treated TB; Purified Protein derivative (PPD) or QuantiFERON-TB positive patients (without active TB) unless it is documented that the patient has been adequately treated for TB and can start treatment with a biologic agent, based on the medical judgment of the site investigator and/or an infectious disease specialist; suspected extrapulmonary TB infection; or at high risk of contracting TB, such as close contact with individual with active or latent TB."}
• {"criterion_text":"- Prior treatment with non-TNFi bDMARDs and/or any JAKi"}
• {"criterion_text":"- Prior treatment with more than one TNFi molecule; exposure to more than one biosimilar of the same TNFi molecule is allowed"}
• {"criterion_text":"- Any live attenuated vaccine, such as varicella-zoster, oral polio, measles, mumps or rubella vaccines, within 4 weeks prior to the baseline visit and throughout the study. Killed or inactive vaccine may be permitted based on the investigator’s judgment."}
• {"criterion_text":"- History of hypersensitivity or allergic reaction to any study drug or any of its excipients (inactive ingredients)."}
• {"criterion_text":"- Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than or equal to 1.5 x upper limit of normal (ULN) for age and sex"}
• {"criterion_text":"- Serum creatinine > 1.5 x ULN for age and sex"}
• {"criterion_text":"- Platelet count <150 x 10^3/microlitre (<150,000/mm^3)"}
• {"criterion_text":"- Hemoglobin less than or equal to 9.0 g/dL (less than or equal to 5.6 mmol/L)"}
• {"criterion_text":"- White blood cell (WBC) count <3,000/mm^3 (<3.0 x 10^9/L)"}
• {"criterion_text":"- Neutrophil count less than or equal to 2000/mm^3 (less than or equal to 2.0 x 10^9/L)"}
• {"criterion_text":"- Absolute lymphocyte count less than or equal to 500 cells/m^3"}

Primary endpoints

• {"endpoint_text":"- Minimal disease activity (MiDA) at Month 6 as assessed by the cJADAS10 less than or equal to 5","definition_or_measurement_approach":"Assessed by the clinical Juvenile Arthritis Disease Activity Score-10 (cJADAS10) with MiDA defined as cJADAS10 ≤5 at Month 6."}

Secondary endpoints

• {"endpoint_text":"- PROMIS® pain interference at Month 6","definition_or_measurement_approach":"Measured using PROMIS® pain interference instrument at Month 6."}
• {"endpoint_text":"- PROMIS® fatigue at Month 6","definition_or_measurement_approach":"Measured using PROMIS® fatigue instrument at Month 6."}
• {"endpoint_text":"- PROMIS® mobility at Month 6","definition_or_measurement_approach":"Measured using PROMIS® mobility instrument at Month 6."}
• {"endpoint_text":"- Change in arthritis disease activity (cJADAS10 and JIA American College of Rheumatology Pediatric 70 [ACR 70]) at Month 6","definition_or_measurement_approach":"Change assessed via cJADAS10 and JIA ACR Pediatric 70 criteria at Month 6."}
• {"endpoint_text":"- Change in arthritis disease activity (cJADAS10) at Month 12","definition_or_measurement_approach":"Change in cJADAS10 measured at Month 12."}

Italy

Earliest CTIS Part Ii Submission Date

14-01-2026

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

27

Number Of Sites

1

Number Of Participants

15

Netherlands

Earliest CTIS Part Ii Submission Date

14-01-2026

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

33

Number Of Sites

1

Number Of Participants

15

Germany

Earliest CTIS Part Ii Submission Date

28-01-2026

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

27

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Duke Clinical Research Institute

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

United States