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

Официальное название

Optimizing Treatment for Children and Adolescents With Juvenile Idiopathic Arthritis in Sustained Remission: a Comparison of Three Treatment Strategies. The MOVE-JIA Trial

Обзор

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.

Вмешательства

• Препарат Methotrexate
  Gradual withdrawal of the medication
• Препарат TNF Inhibitor
  Gradual withdrawal of the medication

Первичные конечные точки

• Proportion of patients with disease flare [Срок оценки: 4, 8 and 12 months]
• Proportion of patients with disease flare between two different withdrawal strategies [Срок оценки: 4, 8 and 12 months]

Вторичные конечные точки (8)

• Time to disease flare [Срок оценки: 4, 8 and 12 months]
• Time to regain inactive disease by the Wallace definition* after flare [Срок оценки: 4, 8 and 12 months]
• Physician global assessment of disease activity [Срок оценки: 4, 8 and 12 months]
• Disease activity assessed by joint count [Срок оценки: 4, 8 and 12 months]
• Patient's/parent's global assessment of well-being [Срок оценки: 4, 8 and 12 months]
• Concentration of Erythrocyte sedimentation rate (ESR), [Срок оценки: 4, 8 and 12 months]
• Concentration of C-reactive protein (CRP) [Срок оценки: 4, 8 and 12 months]
• Numbers and type of adverse events (AE) [Срок оценки: 4, 8 and 12 months]

Критерии участия

Критерии включения

• Participant must be 2-<18 years of age at the time of signing the informed consent.
• Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic Juvenile Idiopathic Arthritis (JIA).
• Inactive disease for ≥12 months documented at a minimum of 2 consecutive visits and documented inactive disease according to Wallace criteria at inclusion, and no active uveitis for ≥24 months.
• Stable treatment with methotrexate and Tumor Necrosis Factor inhibitor (TNFi) for ≥6 months. Weight adjustments permitted.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
• Male participants: No contraceptive measures necessary.
• Female participants: contraception guidance for women of childbearing potential (WOCP).

Критерии исключения

• Chronic widespread pain syndrome
• Major comorbidity including uncontrolled infectious, neurological or mental disease, malignant disease, severe heart failure, severe renal failure, active ulcus ventriculi, and uncontrolled diabetes mellitus.
• Use of oral, intra-articular, intramuscular or intravenous corticosteroids due to JIA less than 12 months prior to randomization.
• Participating in an ongoing clinical randomized study..
• Drug/alcohol abuse which hampers adherence to the study protocol as based on the investigators judgement.
• Language barriers that hamper adherence to the study protocol.
• Pregnancy or breastfeeding.
• Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures.
• Unwillingness to use safe contraception for sexually active WOCP.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 7 центров

• Haukeland University Hospital — Bergen
• Drammen Hospital — Drammen
• Hospital of Southern Norway Hospital Trust — Kristiansand
• Oslo University Hospital — Oslo
• Stavanger University Hospital — Stavanger
• University Hospital of North Norway — Tromsø
• St. Olavs Hospital — Trondheim

Публикации

• Hetlevik SO, Lilleby V, Pesonen M, Nordal E, Rygg M, Austad C, Jonsson MK, Bilstad M, Hoiberg HK, Sande NK, Flato B, Lillegraven S, Haavardsholm EA, Ramanan AV, Molberg O, Boyesen P, Aga AB. 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 fact PMID 41703606

Идентификаторы

NCT: NCT06653634 · 2024-513017-12-00 · 2024-513017-12-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗