Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Study of Medications for Juvenile Arthritis
Plain English Summary
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis is a Phase 3 clinical trial sponsored by Duke University studying Polyarticular Course Juvenile Idiopathic Arthritis (JIA). Tests 3 non-TNF medications in children with Juvenile Idiopathic Arthritis who didn't respond to TNFi treatments. For children aged 2-18 with active arthritis despite TNFi treatment. Participation involves taking different medications in a sequence and monitoring symptoms and side effects. Alternatives include continuing current TNFi treatment or other non-TNF medications. The trial aims to enroll 400 participants.
Official 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).
Who Can Participate
Here is what you need to know about eligibility for this trial. Can join if you have active polyarticular Juvenile Idiopathic Arthritis and have tried a TNFi for at least 3 months. Can't join if you have systemic JIA, enthesitis-related arthritis, or other specific conditions. Age requirement is 2-18 years, and you must weigh at least 10kg. Must not be taking systemic glucocorticoids or have certain infections. This trial is studying Polyarticular Course Juvenile Idiopathic Arthritis (JIA), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures the number of participants with minimal disease activity after 6 months of treatment. The specific primary outcome measures are: Number of participants with MiDA (Month 6). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to find better treatment options for children with Juvenile Idiopathic Arthritis who haven't responded to TNFi medications. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Polyarticular Course Juvenile Idiopathic Arthritis (JIA), where improved treatment options are needed.
Investor Insight
The market for pediatric arthritis treatments is growing, with limited options for those who don't respond to TNFi, making this trial significant. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if you have any of the conditions listed in the exclusion criteria. You will take different medications in a sequence and be monitored for side effects and disease activity. This trial is currently recruiting participants. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: SEQUENTIAL
- Masking: NONE
- Enrollment: 400 participants
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
Primary Outcomes
- Number of participants with MiDA (Month 6)
Secondary Outcomes
- PROMIS® Pain Interference at Month 6 (Month 6)
- PROMIS® Fatigue at Month 6 (Month 6)
- PROMIS® Physical Function at Month 6 (Month 6)
- Change in arthritis disease activity (cJADAS10) (Month 6)
- Change in arthritis disease activity (JIA American College of Rheumatology Pediatric 70 [ACR 70]) at Month 6 (Month 6)
Full Eligibility Criteria
Inclusion 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 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 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
Trial Locations
- 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
Frequently Asked Questions
What is clinical trial NCT06654882?
NCT06654882 is a Phase 3 INTERVENTIONAL study titled "Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis." It is currently recruiting and is sponsored by Duke University. The trial targets enrollment of 400 participants.
What conditions does NCT06654882 study?
This trial investigates treatments for Polyarticular Course Juvenile Idiopathic Arthritis (JIA). The primary condition under study is Polyarticular Course Juvenile Idiopathic Arthritis (JIA).
What treatments are being tested in NCT06654882?
The interventions being studied include: TNFi (Tumor Necrosis Factor inhibitor) medication (DRUG), Abatacept (DRUG), Tocilizumab (DRUG), Tofacitinib (DRUG). 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
What does Phase 3 mean for NCT06654882?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06654882?
This trial is currently "Recruiting." It started on 2026-01-09. The estimated completion date is 2026-12.
Who is sponsoring NCT06654882?
NCT06654882 is sponsored by Duke University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06654882?
The trial aims to enroll 400 participants. The trial is currently recruiting and accepting new participants.
How is NCT06654882 designed?
This is a interventional study, uses randomized allocation, follows a sequential design, employs none masking.
What are the primary outcomes being measured in NCT06654882?
The primary outcome measures are: Number of participants with MiDA (Month 6). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06654882 being conducted?
This trial is being conducted at 5 sites, including San Francisco, California; Gainesville, Florida; Hackensack, New Jersey; Columbus, Ohio and 1 more sites (United States, Germany).
Where can I find official information about NCT06654882?
The official record for NCT06654882 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06654882. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06654882 testing in simple terms?
Tests 3 non-TNF medications in children with Juvenile Idiopathic Arthritis who didn't respond to TNFi treatments. For children aged 2-18 with active arthritis despite TNFi treatment.
Why is this trial significant?
This trial aims to find better treatment options for children with Juvenile Idiopathic Arthritis who haven't responded to TNFi medications. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06654882?
Possible side effects include injection site reactions, infections, and allergic reactions. Monitor for signs of infection and report any side effects to your doctor. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06654882?
Ask your doctor if you have any of the conditions listed in the exclusion criteria. You will take different medications in a sequence and be monitored for side effects and disease activity. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06654882 signal from an investment perspective?
The market for pediatric arthritis treatments is growing, with limited options for those who don't respond to TNFi, making this trial significant. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves taking different medications in a sequence and monitoring symptoms and side effects. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.