Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
- Polyarticular Course Juvenile Idiopathic Arthritis (JIA)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Duke University
- Enrolment target
- 400
- Started
- 9 January 2026
- Main results due
- 30 May 2029
- Study sites
- 7
- Registry updated
- 25 September 2026
Can you take part?
- Ages 2 years to 21 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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).
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(7)
University of California San Francisco Pediatric Rheumatology
San Francisco, California, United States
Recruiting
University of Florida
Gainesville, Florida, United States
Recruiting
Hackensack Meridian Health - Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, United States
Recruiting
Nationwide Children's Hospital
Columbus, Ohio, United States
Recruiting
Asklepios Children's Hospital
Sankt Augustin, North Rhine-Westphalia, Germany
Recruiting
IRCCS Giannina Gaslini Institute
Genoa, Liguria, Italy
Recruiting
University Medical Center Utrecht (Universitair Medisch Centrum Utrecht)
Utrecht, Utrecht, Netherlands
Recruiting
Showing 7 of 7 sites. 7 of the 7 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06654882. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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