Optimizing Treatment for Children and Adolescents with Juvenile Idiopathic Arthritis in Sustained Remission: a Comparison of Three Treatment Strategies. the MOVE-JIA Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Proportion of patients with disease flare
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Stable treatment
Stable treatment with methotrexate and TNFi
干预措施: Methotrexate (Drug)
Stable treatment
Stable treatment with methotrexate and TNFi
干预措施: TNF Inhibitor (Drug)
Methotrexate withdrawal
Gradual withdrawal of methotrexate
干预措施: Methotrexate (Drug)
TNFi withdrawal
Gradual withdrawal of TNFi
干预措施: TNF Inhibitor (Drug)
结局指标
主要结局
Proportion of patients with disease flare
时间窗: 4, 8 and 12 months
Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease Activity Score 27 (JADAS-27\*) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents that a clinically significant flare has occurred with need of intensification of antirheumatic treatment. \*JADAS-27 is a composite measure of juvenile idiopathic arthritis (JIA) disease activity, calculated as a sum of scores from four components giving a score of 0-57. The components included are physician global assessment of disease activity, parent/patient's global assessment of well-being, active joint count of 27 joints and erythrocyte sedimentation rate (ESR) normalized to a 0-10 scale.
Proportion of patients with disease flare between two different withdrawal strategies
时间窗: 4, 8 and 12 months
Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease Activity Score 27 (JADAS-27\*) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents that a clinically significant flare has occurred with need of intensification of antirheumatic (DMARD) treatment. \*JADAS-27 is a composite measure of JIA disease activity, calculated as a sum of scores from four components giving a score of 0-57. The components included are physician global assessment of disease activity, parent/patient's global assessment of well-being, active joint count of 27 joints and ESR normalized to a 0-10 scale.
次要结局
- Time to disease flare(4, 8 and 12 months)
- Time to regain inactive disease by the Wallace definition* after flare(4, 8 and 12 months)
- Physician global assessment of disease activity(4, 8 and 12 months)
- Disease activity assessed by joint count(4, 8 and 12 months)
- Patient's/parent's global assessment of well-being(4, 8 and 12 months)
- Concentration of Erythrocyte sedimentation rate (ESR),(4, 8 and 12 months)
- Concentration of C-reactive protein (CRP)(4, 8 and 12 months)
- Numbers and type of adverse events (AE)(4, 8 and 12 months)
研究者
Anna-Birgitte Aga
Coordinating Investigator
Oslo University Hospital