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

TL;DR

This study aims to find the best way to safely reduce or stop medications in children with juvenile arthritis who are in long-term remission.

Contribution

The study introduces a novel randomized trial comparing methotrexate and TNFi withdrawal strategies in JIA patients in sustained remission.

Findings

The trial will assess the rate of disease flare after medication withdrawal compared to stable treatment.

It will provide evidence for safe tapering and withdrawal strategies in JIA patients.

Results will inform new treatment recommendations for JIA care.

Abstract

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.

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.

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.

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.

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