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New trial aims to solve JIA treatment puzzle after first drug fails
NCT ID NCT06654882
First seen Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 3 times
Summary
This study is for children aged 2 to 17 with polyarticular juvenile idiopathic arthritis (JIA) whose first TNF inhibitor medication did not work well enough. It compares three different non-TNFi drugs (abatacept, tocilizumab, tofacitinib) against a second TNF inhibitor to see which works best. The goal is to find the most effective treatment sequence to reduce disease activity and improve quality of life. 400 participants will be randomly assigned to one of the four options and followed for at least 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Abatacept, Tocilizumab, Tofacitinib, or a second TNF inhibitor (Adalimumab or Etanercept)
- What this could lead to
- If successful, this trial could identify the best treatment sequence for children with JIA whose first TNF inhibitor stops working, helping them achieve low disease activity or remission.
- What could go wrong
- This is a phase 3 trial, but results may not apply to all JIA subtypes. The study is open-label, which can introduce bias, and some children may not respond to any of the tested medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Polyarticular course JIA * Moderate or high-disease activity (cJADAS10 \>5) despite treatment with an initial TNFi for ≥3 months * Age ≥2 years and \<18 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 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 the opinion of the site investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asklepios Children's Hospital
RECRUITINGSankt Augustin, North Rhine-Westphalia, 53757, Germany
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Hackensack Meridian Health - Joseph M. Sanzari Children's Hospital
RECRUITINGHackensack, New Jersey, 07601, United States
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IRCCS Giannina Gaslini Institute
RECRUITINGGenoa, Liguria, 16147, Italy
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Nationwide Children's Hospital
RECRUITINGColumbus, Ohio, 43205, United States
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University of California San Francisco Pediatric Rheumatology
RECRUITINGSan Francisco, California, 94158, United States
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University of Florida
RECRUITINGGainesville, Florida, 32610, United States