Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial

Sponsor
Oslo University Hospital
Study ID
NCT06653634
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    Gradual withdrawal of the medication
  • TNF Inhibitor — DRUG
    Gradual withdrawal of the medication

Study Details

The goal of this clinical trial is to compare three different maintenance and step-down treatment strategies in children and adolescents with juvenile idiopathic arthritis in sustained remission. The main questions it aims to answer are: * Is the proportion of study participants with a disease flare different between each of the two drug withdrawal arms and the stable treatment arm during 12 months? * Does the proportion of study participants with a disease flare differ between the two drug withdrawal arms during 12 months? * How long time does it take before a disease flare occurs, and how long does it take before disease remission is reestablished for participants in the different treatment arms? Participants will be randomized to either A) continued stable treatment with methotrexate and tumor-necrosis alpha inhibitor (TNFi); B) gradual withdrawal of methotrexate while continued stable dose TNFi; or C) gradual withdrawal of TNFi. Participants will be examined every 4 month, and with extra visits if they experience increased symptoms or suspect a disease flare. If a flare occurs, the medications received at study inclusion will be restarted.

Key Dates

Start date
Oct 24, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Stable treatment
    Stable treatment with methotrexate and TNFi
  • Experimental: Methotrexate withdrawal
    Gradual withdrawal of methotrexate
  • Experimental: TNFi withdrawal
    Gradual withdrawal of TNFi

Primary Outcome Measure

Proportion of patients with disease flare [ Time Frame: 4, 8 and 12 months ]

Central Contacts

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