jRCTs031240581招募中不适用
A single-arm, pilot study to evaluate the efficacy and safety of induction therapy of corticosteroids, tacrolimus, and mycophenolate mofetil in patients with anti-ARS antibody syndrome.
未提供0 个研究点目标入组 15 人开始时间: 2025年1月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •The following criteria apply to patients who meet all of the following conditions
- •The patient is at least 18 years old at the time of obtaining consent
- •The patient is newly diagnosed with anti-ARS antibody syndrome based on the following criteria
- •The patient is positive for serum anti-ARS antibodies and has at least one of the following findings (i-ii)
- •i. Progressive interstitial pneumonia: Findings of interstitial pneumonia on chest CT, and worsening over time of any of the following respiratory symptoms, imaging findings, or respiratory function test values associated with interstitial pneumonia
- •ii. Myositis: definite or probable according to the diagnostic criteria for polymyositis/dermatomyositis of Bohan & Peter (1-2)
- •Patients who have given their written consent freely and of their own accord after being fully informed of the study and its procedures
排除标准
- •Received corticosteroids for inflammatory muscle disease or interstitial lung disease within 1 week prior to obtaining consent
- •Received immunosuppressive drugs, TNF inhibitors, IL-6 inhibitors, anti-CD20 monoclonal antibody products, JAK inhibitors, intravenous immunoglobulin or plasma exchange therapy within 12 weeks prior to obtaining consent
- •Comorbidity of other systemic autoimmune diseases (except rheumatoid arthritis and Sjogren's syndrome)
- •On maintenance dialysis or with chronic kidney disease with eGFR less than 30 mL/min/1.73 m2
- •HIV infection, hepatitis B virus or hepatitis C virus infection or history of infection
- •Coexisting active tuberculosis
- •History of malignancy within 5 years (except for intraepithelial carcinoma that is considered curatively resected)
- •Patient has uncontrollable complications
- •Pregnant, seeking pregnancy, within 28 days postpartum, or breastfeeding
- •In the opinion of the principal investigator or subinvestigators, is unfit to safely conduct this study
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