drugset / Trial / NCT06654882
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Phase 3
Recruiting
400 enrolled
Duke University
Patient-Centered Outcomes Research Institute · collab
RandomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2026-01-09
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abatacept | Other / unclassified | 50 mg | Subcutaneous |
| Comparator | Abatacept | Other / unclassified | 87.5 mg | Subcutaneous |
| Comparator | Abatacept | Other / unclassified | 125 mg | Subcutaneous |
| Subject | Adalimumab | Monoclonal antibody | 10 mg | Subcutaneous |
| Subject | Adalimumab | Monoclonal antibody | 20 mg | Subcutaneous |
| Subject | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Etanercept | Protein / enzyme biologic | 0.8 mg/kg | Subcutaneous |
| Subject | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Comparator | Tocilizumab | Monoclonal antibody | 162 mg | Subcutaneous |
| Comparator | Tofacitinib | Small molecule | 3.2 mg | Oral |
| Comparator | Tofacitinib | Small molecule | 4 mg | Oral |
| Comparator | Tofacitinib | Small molecule | 5 mg | Oral |