Moving towards optimized treatment for children and adolescents with juvenile idiopathic arthritis in sustained remission randomized to continue stable treatment, methotrexate withdrawal or tumor necrosis factor inhibitor withdrawal: study protocol for the Norwegian multi-center MOVE-JIA trial.
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BACKGROUND: Juvenile idiopathic arthritis (JIA) used to be a joint-destroying disease, but thanks to modern treatment strategies and medications, many patients with JIA today reach inactive disease. However, once disease remission is achieved, there is a lack of knowledge and recommendations regarding maintenance therapy. Drug-free remission is the ultimate goal in JIA, but withdrawal of medications increases the risk of disease flare. Clinical approaches vary widely, underscoring a need for knowledge about maintenance treatment strategies that allow for safe tapering and withdrawal of medications in JIA patients in sustained remission. The MOVE-JIA study is a randomized, controlled trial with the primary objective to compare the effect of two different treatment withdrawal strategies, to a stable dose of methotrexate (MTX) and tumor necrosis factor inhibitors (TNFi), based on the risk of flares in children and adolescents with JIA with sustained inactive disease. A key secondary objective is the proportion of children with disease flare compared between the two withdrawal groups. METHODS: In this investigator-initiated multicenter, randomized, 3-grouped, parallel, open-label, noninferiority trial, treating physicians at seven Norwegian pediatric rheumatology hospital centers will include 150 patients with JIA. Key eligibility criteria are as follows: Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic JIA, inactive disease for ≥ 12 months documented at a minimum of 2 consecutive visits, and no active uveitis for ≥ 24 months under treatment with stable doses of MTX and TNFi. They will be randomized in a 1:1:1 ratio to (A) stable treatment, (B) methotrexate withdrawal, or (C) TNFi withdrawal. Randomization will be stratified for JIA subtype and study center. For patients in group B and C who are still in remission after 12 months, a new randomization will be performed for complete medication withdrawal for the next 12 months. After 24 months, medication adjustments will be done with shared decision-making. The primary endpoint is the rate of disease flare compared between the drug withdrawal groups and the stable treatment group between baseline and 12 months follow-up. The key secondary endpoint is the proportion with disease flare compared between the two withdrawal groups. Incidence and severity of adverse events will be monitored. DISCUSSION: The results from the MOVE-JIA trial will present an evidence-based treatment strategy for JIA patients with inactive disease. The trial will also give us knowledge about regaining disease remission after flares and possibilities of drug-free remission. All outcomes from the trial will provide a scientific basis for optimized JIA care and result in new treatment recommendations. TRIAL REGISTRATION: EU CT 2024-512017-12-00. Registered on October 24th, 2024; ClinicalTrials.gov NCT06653634. Registered on October 24th, 2024. URL: Study Details | NCT06653634 | Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial | ClinicalTrials.gov. Date of first recruitment: October 24th, 2024.