Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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).
Eligibility
Primary outcome measure(s)
- Number of participants with MiDA — Month 6
Minimal disease activity (MiDA) at Month 6 as assessed by the cJADAS10 ≤5 MiDA is low-disease activity and inactive disease in this protocol. Score range for the cJADAS10 (total): 0 - 30. Disease State cJADAS10 Score Inactive disease ≤2.5 Low-disease activity 2.6 - 5 Moderate-disease activity 5.1 - 16 High-disease activity \>16 Minimal disease activity (MiDA) is a state of low disease activity or remission that is considered a useful treatment target for both patients and physicians. The clinical Juvenile Arthritis Disease Activity Score (cJADAS10) is a tool used to measure the level of disease activity in non-systemic juvenile idiopathic arthritis (JIA). It's a composite index that combines information from several sources, including: * The number of active joints, up to 10 * The physician's global assessment of disease activity (PhGA) * The patient or parental global assessment of well-being (PaGA)
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California San Francisco Pediatric Rheumatology | San Francisco | California | Recruiting |
| University of Florida | Gainesville | Florida | Recruiting |
| Hackensack Meridian Health - Joseph M. Sanzari Children's Hospital | Hackensack | New Jersey | Recruiting |
| Nationwide Children's Hospital | Columbus | Ohio | Recruiting |
| Asklepios Children's Hospital | Sankt Augustin | North Rhine-Westphalia | Recruiting |
| IRCCS Giannina Gaslini Institute | Genoa | Liguria | Recruiting |
| University Medical Center Utrecht (Universitair Medisch Centrum Utrecht) | Utrecht | Utrecht | Recruiting |
On this site
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06654882 on ClinicalTrials.gov ↗ ← All trials in Italy