Real-world Experience With Inhibitors of Janus Kinase for the Treatment of Idiopathic Inflammatory Myopathies -- a Prospective Observational Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Immunological Responses
研究概览
简要总结
This study aims to explore the clinical characteristics and mechanism of inhibitors of janus kinase in the treatment of idiopathic inflammatory myopathies
详细描述
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. Inhibitors of janus kinase including tofacitinib 5 mg once a day or twice a day and baricitinib 2mg once a day or 4mg once a day was administered for 6 months to explore its efficacy and safety, which could help to evaluate inhibitors of janus kinase's 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
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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.
- •Written informed consent should be obtained from each study subject.
- •Concomitant immunosuppressive agents or glucocorticoids were allowed, but subjects should have been on these therapies at least 4 weeks and on a stable dose for ≥4 weeks(glucocorticoid doses are lower than <0.5mg/kg/d).
- •Consent to use effective contraception during the study (women of childbearing age).
排除标准
- •Any subject meeting either of the following criteria should be excluded:
- •Laboratory abnormality: Hb<8 g/dl or platelet<60*10^9/L, or combined with severe hepatic, renal and cardiac insufficiency;
- •Myositis in overlap with another systemic autoimmune rheumatic disorder, cancer-associated myositis, inclusion body myositis or any other non-immune mediated myopathy.
- •Biologics such as rituximab are not allowed in the 3-month before enrollment.
- •Patients with malignancy within 3 years of screening.
- •Patients with hypersensitivity to study drug.
- •Active infections(including but not limited to hepatitis, HIV).
- •Uncontrolled mental or emotional disorders.
研究组 & 干预措施
tofacitinib or baricitinib
Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.
干预措施: tofacitinib (Drug)
结局指标
主要结局
Immunological Responses
时间窗: week 24
Changes of follicular helper T cells (TFH) before and after tofacitinib treatment are analysed to evaluate efficacy.
次要结局
- Myositis Disease Activity Assessment Tool(MDAAT)(week 24)
研究者
HeJing
Professor
Peking University People's Hospital