Actively Recruiting
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Led by Duke University · Updated on 2026-04-16
400
Participants Needed
6
Research Sites
46 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of polyarticular course juvenile idiopathic arthritis (JIA)
- Moderate or high disease activity (cJADAS10 >5) despite initial TNFi treatment for at least 3 months
- Age between 2 and 17 years and weight of at least 10 kg
- No use of systemic glucocorticoids or stable dose of systemic glucocorticoids (≤0.2 mg/kg/day, max 10 mg/day) for at least 2 weeks before baseline visit
- Documented informed consent or assent from parent, caregiver, or patient
You will not qualify if you...
- Systemic juvenile idiopathic arthritis
- Enthesitis-related arthritis or juvenile spondyloarthritis
- History or active inflammatory bowel disease
- History or active psoriasis
- Active uveitis within 3 months before baseline
- History or active sacroiliitis
- History or current malignancy
- Active tuberculosis or incompletely treated tuberculosis, positive TB tests without adequate treatment, suspected extrapulmonary TB, or high risk of TB exposure
- Prior treatment with more than one TNFi molecule (exposure to multiple biosimilars of the same TNFi is allowed)
- Prior treatment with non-TNFi bDMARDs or any JAK inhibitors
- Elevated liver enzymes (AST or ALT ≥3 times upper limit of normal for age and sex)
- High serum creatinine (>1.5 times upper limit of normal for age and sex)
- Low platelet count (<150,000/mm3)
- Severe anemia (hemoglobin <7.0 g/dL)
- Low white blood cell count (<3,000/mm3)
- Low neutrophil count (<1,500/mm3)
- Any active or recent serious infection or recent treatment with intravenous or oral antibiotics
- Any medical condition considered a contraindication or safety concern for study medications by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of California San Francisco Pediatric Rheumatology
San Francisco, California, United States, 94158
Actively Recruiting
2
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
3
Hackensack Meridian Health - Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, United States, 07601
Actively Recruiting
4
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
5
Asklepios Children's Hospital
Sankt Augustin, North Rhine-Westphalia, Germany, 53757
Actively Recruiting
6
IRCCS Giannina Gaslini Institute
Genoa, Liguria, Italy, 16147
Actively Recruiting
Research Team
L
Laura E Schanberg (Contact PI)
CONTACT
H
Huiman Barnhart (Dual PI)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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