New Treatments for Juvenile Idiopathic Arthritis

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

Recruiting Phase 3 Interventional Study
Polyarticular Course Juvenile Idiopathic Arthritis (JIA)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
2 – 21
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for

This trial is looking for children with juvenile idiopathic arthritis who have not responded well to their current treatment. Participants will compare different medications to see which works best after a specific treatment has failed.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with polyarticular juvenile idiopathic arthritis.
  • I am aged between 2 and 18 years old and weigh at least 10 kg.
  • I have moderate to high disease activity despite at least 3 months of treatment with a TNF inhibitor.
  • I have not taken systemic glucocorticoids or have been on a stable, low dose for at least 2 weeks.
  • I have been given informed consent from my parent or caregiver.

You may not be able to join if

  • I have systemic juvenile idiopathic arthritis.
  • I have inflammatory bowel disease or psoriasis.
  • I have active uveitis or sacroiliitis.
  • I have a history of cancer.
  • I currently have active tuberculosis or a history of untreated tuberculosis.
  • I have previously used more than one TNF inhibitor.
  • I have low blood counts or liver enzyme levels that are too high.
  • I have any active major bacterial, viral, or fungal infection.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial
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 no…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * 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 (maximu…
Contacts

Laura E Schanberg (Contact PI)

919-373-3863

laura.schanberg@duke.edu

CONTACT

Huiman Barnhart (Dual PI)

919-668-8828

huiman.barnhart@duke.edu

CONTACT