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Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Sponsor: Duke University
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).
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-01-09
Completion Date
2026-12
Last Updated
2026-03-23
Healthy Volunteers
No
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
Locations (5)
University of California San Francisco Pediatric Rheumatology
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
Hackensack University Medical Center - Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Asklepios Children's Hospital
Sankt Augustin, North Rhine-Westphalia, Germany