Treatment Tapering in Oligoarticular or Rheumatoid Factor Negative Polyarticular Juvenile Idiopathic Arthritis With Inactive Disease on Biologic Therapy
Trial tests reducing biologic medication for children with inactive Juvenile Idiopathic Arthritis.
Plain English Summary
Treatment Tapering in JIA With Inactive Disease is a Phase 3 clinical trial sponsored by Assistance Publique - Hôpitaux de Paris studying Juvenile Idiopathic Arthritis. This trial tested if it's safe to reduce or stop biologic medications in children with a specific type of Juvenile Idioclastic Arthritis (JIA) that is not actively causing symptoms. It was for children aged 2-17 years who had inactive JIA while on certain biologic drugs (etanercept, tocilizumab, adalimumab, or abatacept). Participation involved gradually reducing the dose of their current biologic medication over several months. The alternative was to continue the current stable dose of biologic medication. The trial aims to enroll 62 participants.
Official Summary
As biologic treatments are expensive and associated with some concerns regarding long-term safety, investigator hypothesize that early tapering and then withdrawal of biological agent, in an homogenous group of children with juvenile idiopathic arthritis achieving inactive disease, is safe and not inferior to the maintenance of stable treatment intensity over 24 weeks. In addition, investigator also hypothesize that an earlier tapering of treatment is associated with a better quality-of-life and a general cost saving effect. MRP8/14 will be studied as a potential biomarker for the risk of relapse. A study for biologic agent, anti-biologic agent antibodies and a pharmacogenomic approach will complete the research, as pharmacokinetic study during withdrawal of biologic treatment are rare in children.
Who Can Participate
Here is what you need to know about eligibility for this trial. Children aged 2 to 17 years who were already taking specific biologic medications for JIA. Children must have had inactive disease for less than 12 months, meaning no active joint swelling, normal inflammatory markers, and a doctor's assessment of no active disease. Children with certain types of JIA (systemic, rheumatoid factor positive, psoriatic, or enthesitis-related) were not eligible. Children with active eye inflammation (uveitis) related to JIA or any contraindications to their current biologic drug were also excluded. This trial is studying Juvenile Idiopathic Arthritis, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measured if the children could maintain their inactive disease status for 24 weeks after reducing their medication, meaning their arthritis symptoms did not return. The specific primary outcome measures are: Persistence of inactive disease (24 weeks). 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 matters because it explores if children with inactive JIA can safely reduce or stop expensive biologic treatments, potentially reducing long-term side effects and costs. 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 Juvenile Idiopathic Arthritis, where improved treatment options are needed.
Investor Insight
This trial investigated cost-saving strategies for managing chronic childhood arthritis, a significant market for biologic drugs, with potential implications for treatment guidelines. 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 reducing your current biologic medication is a suitable option for your child's specific JIA. Understand that participation involves a gradual reduction in medication and regular check-ups to monitor for any return of disease activity. Be prepared for potential follow-up visits and tests to assess disease activity and medication levels. The trial is being conducted at 1 site. 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: FACTORIAL
- Masking: NONE
- Enrollment: 62 participants
Interventions
- DRUG: etanercept — will be tapered from every week to every 2 weeks for 12 weeks then to every 3 weeks for 12 weeks
- DRUG: adalimumab — will be tapered from every 2 weeks to every 3 weeks for 12 weeks and to every 4 weeks for 12 weeks
- DRUG: Abatacept — will be tapered from every 4 weeks to every 6 weeks for 24 weeks
- DRUG: Tocilizumab — will be tapered from every 4 weeks to every 6 weeks for 24 weeks
Primary Outcomes
- Persistence of inactive disease (24 weeks)
Secondary Outcomes
- Adverse and serious adverse events or of special interest (Weeks 12, 24, 36, 48, 60, 72)
- Persistent inactive disease as defined by Wallace criteria (72 weeks)
- Juvenile Arthritis Disease Activity Score (JADA score) (Day 0, Weeks 12, 24, 48, 72)
- Biological agent concentrations (Day 0, weeks 12, 24, 36, 48, 60)
- Anti-drugs antibodies concentrations (Day 0, weeks 12, 24, 36, 48, 60)
Full Eligibility Criteria
Inclusion Criteria: * Patient aged 2 to 17 years and treated with etanercept or tocilizumab or adalimumab, or patient aged 6 to 17 years and treated with abatacept. * Patient with an oligoarticular or polyarticular rheumatoid factor negative JIA * Patient treated with biologic treatment for persistent arthritis according to the marketing authorization. * Patient who achieved inactive disease within two years of treatment with the last biologic agent administered, according to Wallace criteria : no joints with active arthritis, no active uveitis (as defined by the SUN Working Group), ESR or CRP level within normal limits in the laboratory where tested (or, if elevated, not attributable to JIA), physician's global assessment of disease activity score (\< 10/100 visual analogue scale), and duration of morning stiffness \< ou = 15 minutes (within 7 days before the visit). * Patient with inactive disease achieved for less than 12 months. * Patient with stable doses of non-steroidal anti-inflammatory drugs, Methotrexate (maximum 20 mg/m2/week), and other non biologic DMARD for at least one month before inclusion * Patient without steroids or joint injection or live vaccines injection for at least one month. * Signed informed consent by both parents (or legal guardian) and patient's agreement. * Patient affiliated to the National Health Assurance system. Exclusion Criteria: * Patient with systemic form, rheumatoid factor positive, psoriatic or associated with enthesitis related JIA. * Patient undergoing biologic therapy due to JIA-associated uveitis or with active uveitis at time of randomization. * Patient with any contraindication to continue ongoing biologic treatment, notably ongoing uncontrolled infection, suspicion or evidence of demyelinating disease of the central nervous system. * Patient previously treated with the same biotherapy for which dose decreasing or biotherapy withdrawal was already tested in the past for inactive disease and then reintroduced. * Pregnancy or absence of effective contraception (including abstinence) in a pubertal patient. * Patient suffering from tuberculosis. * Patient with moderate to severe cardiac failure (NYHA class III / IV).
Trial Locations
- Necker Children's Hospital, Paris, Paris, France
Frequently Asked Questions
What is clinical trial NCT02840175?
NCT02840175 is a Phase 3 INTERVENTIONAL study titled "Treatment Tapering in JIA With Inactive Disease." It is currently completed and is sponsored by Assistance Publique - Hôpitaux de Paris. The trial targets enrollment of 62 participants.
What conditions does NCT02840175 study?
This trial investigates treatments for Juvenile Idiopathic Arthritis. The primary condition under study is Juvenile Idiopathic Arthritis.
What treatments are being tested in NCT02840175?
The interventions being studied include: etanercept (DRUG), adalimumab (DRUG), Abatacept (DRUG), Tocilizumab (DRUG). will be tapered from every week to every 2 weeks for 12 weeks then to every 3 weeks for 12 weeks
What does Phase 3 mean for NCT02840175?
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 NCT02840175?
This trial is currently "Completed." It started on 2017-05-18. The estimated completion date is 2020-10-01.
Who is sponsoring NCT02840175?
NCT02840175 is sponsored by Assistance Publique - Hôpitaux de Paris. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT02840175?
The trial aims to enroll 62 participants. The trial status is completed.
How is NCT02840175 designed?
This is a interventional study, uses randomized allocation, follows a factorial design, employs none masking.
What are the primary outcomes being measured in NCT02840175?
The primary outcome measures are: Persistence of inactive disease (24 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT02840175 being conducted?
This trial is being conducted at 1 site, including Paris, Paris (France).
Where can I find official information about NCT02840175?
The official record for NCT02840175 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT02840175. This government database provides the most up-to-date and detailed information about the trial.
What is NCT02840175 testing in simple terms?
This trial tested if it's safe to reduce or stop biologic medications in children with a specific type of Juvenile Idioclastic Arthritis (JIA) that is not actively causing symptoms. It was for children aged 2-17 years who had inactive JIA while on certain biologic drugs (etanercept, tocilizumab, adalimumab, or abatacept).
Why is this trial significant?
This trial matters because it explores if children with inactive JIA can safely reduce or stop expensive biologic treatments, potentially reducing long-term side effects and costs. 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 NCT02840175?
The main risk is that the JIA could become active again after reducing the medication, leading to a return of symptoms like joint pain and swelling. Other potential risks include experiencing side effects from the biologic medication itself, although the trial aimed to reduce these by lowering doses. There's a possibility of developing antibodies against the biologic drug, which could make it less effective in the future. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT02840175?
Ask your doctor if reducing your current biologic medication is a suitable option for your child's specific JIA. Understand that participation involves a gradual reduction in medication and regular check-ups to monitor for any return of disease activity. Be prepared for potential follow-up visits and tests to assess disease activity and medication levels. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT02840175 signal from an investment perspective?
This trial investigated cost-saving strategies for managing chronic childhood arthritis, a significant market for biologic drugs, with potential implications for treatment guidelines. 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 involved gradually reducing the dose of their current biologic medication over several months. 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.