Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

Conditions

• Polyarticular Course Juvenile Idiopathic Arthritis (JIA)

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

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

Study Details

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).

Key Dates

Start date

Jan 9, 2026

Status verified

Oct 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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 .

Primary Outcome Measure

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

Central Contacts

• Laura E Schanberg (Contact PI)
  919-373-3863
  [email protected]
• Huiman Barnhart (Dual PI)
  919-668-8828
  [email protected]

Locations (4)

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