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.
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…
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).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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 (maximum 10 mg/day) for ≥2 weeks prior to baseline visit
* Documented informed consent/assent obtained from the parent/caregiver/patient
Exclusion Criteria:
* 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 treated for TB and can start treatment with a biologic agent, based on the medical judgment of the site investigator and/or an infectious disease specialist; suspected extrapulmonary TB infection; or at high risk of contracting TB, such as close contact with individual with active or latent TB
* 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 completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit
* Any live attenuated vaccine, such as varicella-zoster, oral polio, measles, mumps or rubella vaccines, within 4 weeks prior to the baseline visit.
* 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 particular, subjects at known high risk for venous thromboembolism will be excluded, including recent heart failure or prior myocardial infarction, known inherited thrombotic risk factors, history of venous thromboembolism (deep venous thrombosis or pulmonary embolism, undergoing major surgery, or are chronically immobilized).
* Pregnant or breastfeeding
* Sexually active females of childbearing potential who refuse to use at least one required contraception method (See Contraception paragraph 8.9 for definition of childbearing potential and details).
* History of hypersensitivity or allergic reaction to any study drug or any of its excipients (inactive ingredients).
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.