Phase 3: testing TNFi (Tumor Necrosis Factor inhibitor) medication for Polyarticular Course Juvenile Idiopathic Arthritis (JIA)
This study is an open-label, randomly assigned, 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 randomly assigned 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.
Official registry: https://clinicaltrials.gov/study/NCT06654882 · Duke University · enrollment listed as 400
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are TNFi (Tumor Necrosis Factor inhibitor) medication, Abatacept, or Tocilizumab. The registry lists allocation as randomized. This study is an open-label, randomly assigned, 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 randomly assigned trial design with 2 randomization stages corresponding with clinical decision points.
They plan to enroll about 400 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Interventions: TNFi (Tumor Necrosis Factor inhibitor) medication, Abatacept, Tocilizumab, Tofacitinib
Primary outcome (registry wording): Number of participants with MiDA
Who it is for (from inclusion criteria)
- Ages 2 Years to 21 Years
- Polyarticular course JIA
- Moderate or high-disease activity (cJADAS10 \>5) despite treatment with an initial TNFi for ≥2 months
- Age ≥2 years and \<21 years and weight ≥ 10kg
- No systemic glucocorticoids or systemic glucocorticoids at a stable dose of ≤0.2 mg/kg/day (maximum 10 mg/day) for ≥2 weeks prior to baseline visit
Who the registry excludes
- Enthesitis-related arthritis/juvenile spondyloarthritis (2001 International League of Associations for Rheumatology \[ILAR\] criteria)30
- History of or currently active inflammatory bowel disease
- History of or currently active psoriasis
- Active uveitis within 3 months of the baseline visit
- History of or currently active sacroiliitis
- History of or current malignancy
- Prior treatment with more than one TNFi molecule; exposure to more than one biosimilar of the same TNFi molecule is allowed
Public study contact (from the registry)
Laura E Schanberg (Contact PI)
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
7 listed- 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)
+ 3 sites outside the US on the same record
FAQ about this NCT record
Is NCT06654882 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06654882?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06654882?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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