Recruiting
Phase 3

Non-TNFi Medications

Sponsor:

Duke University

Code:

NCT06654882

Conditions

Polyarticular Course Juvenile Idiopathic Arthritis (JIA)

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

TNFi (Tumor Necrosis Factor inhibitor) medication

Abatacept

Tocilizumab

Tofacitinib

Study Details

Brief summary:

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).

Conditions

Polyarticular Course Juvenile Idiopathic Arthritis (JIA)

Study ID

NCT06654882

Start date

Jan 9, 2026

Status verified date

Oct, 2025

Completion date

Nov, 2029

Anticipated

Primary completion date

May 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Second TNFi (Tumor Necrosis Factor inhibitor) medication

Adalimumab originator or biosimilar; etanercept originator or biosimilar depending on which TNFi the participant had failed.

active comparator: Abatacept

The 50 mg, 87.5 mg and 125 mg SQ doses will be available for weight-based dosing. All participants randomized to abatacept in the first or second stage randomization will receive abatacept SQ weekly at a dosage based on the participant's body weight

active comparator: Tocilizumab originator or biosimilar

Tocilizumab will be provided in prefilled syringes (162 mg tocilizumab/0.9 mL solution). All participants randomized to tocilizumab in the first or second stage randomization will be receiving 1 prefilled syringe (162 mg) with a dosing interval based on the body weight criteria.

active comparator: Tofacitinib

Tofacitinib will be provided as oral tablets (tofacitinib citrate 5 mg) and as an oral solution (1 mg/mL). All participants randomized to tofacitinib in the first or second stage randomization will receive tofacitinib oral tablets or oral solution twice daily, approximately 12 hours apart, in the morning and evening, at a dosage based on the participant's body weight .

Interventions

TNFi (Tumor Necrosis Factor inhibitor) medication

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

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

<30 kg 162 mg once every 3 weeks

≥30 kg 162 mg once every 2 weeks

Tofacitinib

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

Primary outcome measure

  • Number of participants with MiDA [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Laura E Schanberg (Contact PI)

919-373-3863laura.schanberg@duke.edu

Huiman Barnhart (Dual PI)

919-668-8828huiman.barnhart@duke.edu

Locations

University of California San Francisco Pediatric Rheumatology

Recruiting

San Francisco, California, United States, 94158

Contacts

Study Coordinator

415-353-1301zilan.zheng@ucsf.edu

Principal Investigator:

Susan Kim

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Study Coordinator

352-294-8556melissa.lingis@peds.ufl.edu

Principal Investigator:

Melissa Elder

Hackensack Meridian Health - Joseph M. Sanzari Children's Hospital

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Clinical Research Coordinator

551-996-3345kate.sidwell@hmhn.org

Principal Investigator:

Ginger Janow

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Study Coordinator

614-722-5525joanne.drew@nationwidechildrens.org

Principal Investigator:

Alysha Taxter

More Information

Sponsor

Duke University

Last update posted

Aug 3, 2026

Last verified

Oct, 2025

Keywords

  • JIA
  • Rheumatology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-03.