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KVINNEHELSE-Kvinners helse og kjønnsperspektiver

Moving towards evidence-based treatment strategies for children with juvenile idiopathic arthritis in sustained remission: The MOVE-JIAtrial

Alternative title: På vei mot evidensbaserte behandlingsstrategier for barn med juvenil idiopatisk artritt i vedvarende remisjon: MOVE-JIA-studien

Awarded: NOK 11.0 mill.

In this randomized controlled trial, we aim to optimize the management of patients with juvenile idiopathic arthritis (JIA) who are in stable disease remission. Balancing the risk of JIA flare with the long-term burden of medications and their side effects is a crucial concern for patients, parents, and caregivers. JIA is the most common chronic rheumatic condition in children and adolescents, predominantly affecting girls. The disease causes joint inflammation and can lead to joint damage and disability. Fortunately, due to modern medications and treatment strategies, many JIA patients can achieve "sustained remission" – with no symptoms of the disease. But there is a question that lingers: how best to manage JIA patients once they are in remission? The answer is not clear as there are no controlled studies to guide us, and there are no recommendations on whether to reduce or withdraw the treatment. Introducing the "MOVE-JIA" trial: a national study that will include JIA patients in sustained remission treated with tumor necrosis factor-inhibitor (TNFi) and methotrexate. They will be randomly divided into three groups: A) Gradual TNFi withdrawal, B) Gradual methotrexate withdrawal, or C) Continued stable treatment with both TNFi and methotrexate. The primary goal is to measure how many patients experience a disease flare within a year. The MOVE-JIA trial will be the first study to investigate if reducing MTX is less likely to cause disease flares compared to reducing TNFi in JIA patients. The study will also assess whether single treatment with either TNFi or methotrexate is as effective as combination of both treatments. The MOVE-JIA trial is a collaborative national effort, including all pediatric rheumatology units in Norway and active patient participation, ensuring the swift application of the results into clinical practice. The findings will provide much-needed insights on how to best manage children and adolescents with JIA who are in remission.

Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children and adolescents and occurs 3-6 times more often in girls. It is characterized by joint inflammation with a potential for joint destruction and disability if not treated. Sustained remission (no sign of active disease) is an achievable goal in JIA after the introduction of biological agents such as inhibitors of tumor necrosis factor (TNFi) and treat-to-target strategies. However, strategies to best treat JIA patients in remission remains unclear. No controlled studies have addressed the effect of tapering strategies for JIA in remission, and there are no current recommendations for stepdown or optimizing maintenance treatment. Given the risks, side effects and costs of JIA medications, treatment withdrawal can give patients and families relief and improve their quality of life. The MyJIA-Ahead trial is a national, investigator initiated, multicenter, 36 months, RCT of JIA patients in sustained remission on TNF-inhibitor and methotrexate. 150 JIA patients will be randomized 1:1:1 at baseline to A) Stepwise withdrawal of TNFi, B) Stepwise withdrawal of MTX, or C) Continued stable treatment with TNFi and MTX. The primary endpoint is proportion of patients with disease flare within 12 months. Key secondary endpoints are time to flare and time to regain remission after flare. If a disease flare occurs, the patient will return to the full dose study medication (the treatment the patient was receiving at baseline). Exploration of risk factors for disease flare includes patients reported health status and preferences, clinical characteristics, immunogenicity, molecular signalling (transcriptional, cellular and genetic risk) and ultrasound assessment of synovitis. While evidence-based advice for starting therapies in active disease is available, The MyJIA-Ahead will provide much needed knowledge about treatment continuation in children and young adults with JIA in remission.

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KVINNEHELSE-Kvinners helse og kjønnsperspektiver

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