RECRUITING Phase 3 ClinicalTrials.gov

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

Sponsor: Duke University • ClinicalTrials.gov ID: NCT06654882

Registry updated: 2026-09-25

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

This study is an open-label, randomized, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomized trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi. The second randomization allows identification of optimal sequential use of biologics (treatment strategies).

Interventions

TNFi (Tumor Necrosis Factor inhibitor) medication (Drug)
Adalimumab 10 kg (22 lbs) to \<15 kg (33 lbs) 10 mg every other week\* 15 kg (33 lbs) to \<30 kg (66 lbs) 20 mg every other week ≥30 kg (66 lbs) 40 mg every other week Etanercept ≥63 kg (138 lb) 50 mg weekly \<63 kg (138 lb) 0.8 mg/kg weekly
Abatacept (Drug)
10 kg to \<25 kg 50 mg once weekly 25 kg to \<50 kg 87.5 mg once weekly ≥50 kg 125 mg once weekly
Tocilizumab (Drug)
\<30 kg 162 mg once every 3 weeks ≥30 kg 162 mg once every 2 weeks
Tofacitinib (Drug)
10 to \<20 kg 3.2 mg (3.2 mL oral solution) BID 20 to \<40 kg 4 mg (4 mL oral solution) BID ≥40 kg 5 mg (one 5 mg tablet or 5 mL oral solution) BID

Eligibility criteria

Inclusion Criteria: * Polyarticular course JIA * Moderate or high-disease activity (cJADAS10 \>5) despite treatment with an initial TNFi for ≥2 months * Age ≥2 years and \<21 years and weight ≥ 10kg * No systemic glucocorticoids or systemic glucocorticoids at a stable dose of ≤0.2 mg/kg/day (maximum 10 mg/day) for ≥2 weeks prior to baseline visit * Documented informed consent/assent obtained from the parent/caregiver/patient Exclusion Criteria: * Systemic JIA * Enthesitis-related arthritis/juvenile spondyloarthritis (2001 International League of Associations for Rheumatology \[ILAR\] criteria)30 * History of or currently active inflammatory bowel disease * History of or currently active psoriasis * Active uveitis within 3 months of the baseline visit * History of or currently active sacroiliitis * History of or current malignancy * 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 * Prior treatment with more than one TNFi molecule; exposure to more than one biosimilar of the same TNFi molecule is allowed * Prior treatment with non-TNFi bDMARDs and/or any JAKi * Aspartate aminotransferase (AST) or alanine transaminase (ALT) ≥3 × upper limit of normal (ULN) for age and sex * Serum creatinine \>1.5 × ULN for age and sex * Platelet count \<150 × 103/μL (\<150,000/mm3) * Hemoglobin \<7.0 g/dL (\<4.3 mmol/L) * White blood cell (WBC) count \<3,000/mm3 (\<3.0 × 109/L) * Neutrophil count \<1,500/mm3 (\<1.5 × 109/L) * Any active acute, subacute, chronic, or recurrent bacterial, viral, 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 * Any live attenuated vaccine, such as varicella-zoster, oral polio, measles, mumps or rubella vaccines, within 4 weeks prior to the baseline visit. * Any medical history that may be considered a contraindication/safety concern with the use of adalimumab, etanercept, tofacitinib, ABA, or an IL-6 inhibitor or their biosimilars. In particular, subjects at known high risk for venous thromboembolism will be excluded, including recent heart failure or prior myocardial infarction, known inherited thrombotic risk factors, history of venous thromboembolism (deep venous thrombosis or pulmonary embolism, undergoing major surgery, or are chronically immobilized). * Pregnant or breastfeeding * Sexually active females of childbearing potential who refuse to use at least one required contraception method (See Contraception paragraph 8.9 for definition of childbearing potential and details). * History of hypersensitivity or allergic reaction to any study drug or any of its excipients (inactive ingredients).

Conditions

Polyarticular Course Juvenile Idiopathic Arthritis (JIA)

Locations

University of California San Francisco Pediatric Rheumatology — San Francisco, California, United States
University of Florida — Gainesville, Florida, United States
Hackensack Meridian Health - Joseph M. Sanzari Children's Hospital — Hackensack, New Jersey, United States
Nationwide Children's Hospital — Columbus, Ohio, United States
Asklepios Children's Hospital — Sankt Augustin, North Rhine-Westphalia, Germany
IRCCS Giannina Gaslini Institute — Genoa, Liguria, Italy
University Medical Center Utrecht (Universitair Medisch Centrum Utrecht) — Utrecht, Utrecht, Netherlands

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment