Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06654882
PHASE3

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

Sponsor: Duke University

View on ClinicalTrials.gov

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

DRUG

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

DRUG

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

DRUG

Tocilizumab

\<30 kg 162 mg once every 3 weeks ≥30 kg 162 mg once every 2 weeks

DRUG

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