Real-world Experience With Deucravacitinib for the Treatment of Idiopathic Inflammatory Myopathies -- a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- IMACS-defined improvement
研究概览
简要总结
This study aims to explore the clinical characteristics and mechanism of Deucravacitinib in the treatment of idiopathic inflammatory myopathies.Detailed Description: The investigators designed a single center, open-label, prospective study. Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan & Peter Dermatomyositis/Polymyositis(DM/PM) or Rheumatology(ACR) & European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria. Deucravacitinib 6 mg once a day was administered for 6 months to explore its efficacy and safety, which could help to evaluate Deucravacitinib clinical characteristics and mechanism. Patients would be evaluated the improvement of clinical and laboratory indexes. Changes of symptoms, immune cell subsets and cytokines were monitored. Symptoms were evaluated by Visual Analogue Scale (VAS) of patient global and physician global, manual muscle testing(MMT-8), the Health Assessment Questionnaire(HAQ), Creatine kinase, Myositis Disease Activity Assessment Tool(MDAAT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 years and 75 years of age.
- •Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan & Peter DM/PM or American College of Rheumatology(ACR) & European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria.
- •Active disease: MDAAT skin VAS ≥ 3 cm, with at least 3 core indicators abnormal;
- •Inadequate response to or intolerance of conventional treatments (such as glucocorticoids, immunosuppressants).
排除标准
- •Any subject meeting either of the following criteria should be excluded:
- •Combined with other systemic autoimmune diseases;
- •Severe hepatic and renal dysfunction;
- •Active infections (such as tuberculosis, hepatitis B, HIV);
- •Pregnant or lactating women;
- •Previous use of JAK inhibitors.
结局指标
主要结局
IMACS-defined improvement
时间窗: week 24
The International Myositis Assessment and Clinical Studies (IMACS) definition of improvement (DOI) criteria require improvement of ≥20% in at least three of the six Core Symptom Metrics (CSMs), with no more than two CSMs showing a worsening of ≥25% (excluding MMT-8);
次要结局
未报告次要终点
研究者
He Jing
Principal Investigator
Peking University People's Hospital