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New treatment option for Polyarticular Course Juvenile Idiopathic Arthritis (JIA)
Official title Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
ClinicalTrials.gov ID: NCT06654882
What this study is testing
What is TNFi (Tumor Necrosis Factor inhibitor) medication?
TNFi (Tumor Necrosis Factor inhibitor) medication is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for polyarticular course juvenile idiopathic arthritis (jia).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Polyarticular course JIA
- Moderate or high-disease activity (cJADAS10 \>5) despite treatment with an initial TNFi for ≥3 months
- Age ≥2 years and \<18 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
- Documented informed consent/assent obtained from the parent/caregiver/patient
You likely can't join if
- Systemic JIA
- 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
See the full eligibility criteria
- Polyarticular course JIA
- Moderate or high-disease activity (cJADAS10 \>5) despite treatment with an initial TNFi for ≥3 months
- Age ≥2 years and \<18 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
- Documented informed consent/assent obtained from the parent/caregiver/patient
- Systemic JIA
- 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
- Active tuberculosis (TB) or a history of incompletely treated TB; Purified Protein derivative (PPD) or QuantiFERON-TB positive patients (without active TB) unless it is documented that the patient has been adequately...
- Prior treatment with more than one TNFi molecule; exposure to more than one biosimilar of the same TNFi molecule is allowed
- Prior treatment with non-TNFi bDMARDs and/or any JAKi
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) ≥3 × upper limit of normal (ULN) for age and sex
- Serum creatinine \>1.5 × ULN for age and sex
- Platelet count \<150 × 103/μL (\<150,000/mm3)
- Hemoglobin \<7.0 g/dL (\<4.3 mmol/L)
- White blood cell (WBC) count \<3,000/mm3 (\<3.0 × 109/L)
- Neutrophil count \<1,500/mm3 (\<1.5 × 109/L)
- Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics...
- Any medical history that may be considered a contraindication/safety concern with the use of adalimumab, etanercept, tofacitinib, ABA, or an IL-6 inhibitor or their biosimilars, in the opinion of the site investigator
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Gainesville, Florida, United States
- Hackensack, New Jersey, United States
- Columbus, Ohio, United States
- Sankt Augustin, North Rhine-Westphalia, Germany
- Genoa, Liguria, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Gainesville, Florida, United States; Hackensack, New Jersey, United States; Columbus, Ohio, United States; Sankt Augustin, North Rhine-Westphalia, Germany; Genoa, Liguria, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.