Clinical Trial

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

Study acronym: SMART-JIA
Recruiting Phase 3
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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).
Protocol Amendment History 3 changes
notable Primary completion pushed: 2026-12 -> 2029-05-30 2026-08-04
minor Completion pushed: 2026-12 -> 2029-11 2026-08-04
notable Primary completion pushed: 2026-06 -> 2026-12 2026-06-02
Trial Details
NCT Number NCT06654882
Lead Sponsor Duke University
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Polyarticular Course Juvenile Idiopathic Arthritis (JIA)
Enrollment 400 participants
Start Date 2026-01-09
Primary Completion 2029-05-30 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-03