NCT07355257尚未招募2 期
Safety and Efficacy of Telitacicept in Inflammatory Myopathies
Zhongming Qiu0 个研究点目标入组 30 人开始时间: 2026年2月2日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of Telitacicept in the treatment of inflammatory myopathy in patients with inflammatory diseases. The main question it aims to answer is: the safety and effectiveness of Telitacicept in treating inflammatory myopathy.
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
盲法说明
Masking Description
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
- •Age ≥ 18 years and ≤ 70 years.
- •Patient has a confirmed diagnosis of inflammatory myopathy, meeting the 2017 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for idiopathic inflammatory myopathies.
- •Inadequate response or intolerance to glucocorticoids and/or at least one immunosuppressant.
- •The patient or their legal guardian provides written informed consent.
排除标准
- •Female patients who are pregnant, breastfeeding, or planning a pregnancy during the trial period.
- •Patients with active infections, such as herpes zoster, HIV, active tuberculosis, active hepatitis, HBsAg-positive patients, or HCV antibody-positive patients.
- •Patients with positive test results indicating COVID-19 infection within 1 month prior to baseline.
- •Patients with a history of or currently diagnosed malignancy.
- •Patients with significant cardiovascular diseases (including severe arrhythmia), hepatic, renal, respiratory, endocrine, or hematological disorders, or any other medical condition that, in the investigator's judgment, would interfere with participation in the study or require hospitalization during the trial.
- •Patients who have received intravenous immunoglobulin (IVIG) or plasmapheresis within 1 month prior to baseline.
- •Patients who have received other targeted biologic therapies, such as rituximab, eculizumab, tocilizumab, etc., within 3 months prior to baseline.
- •Patients who have received any live vaccine within 3 months prior to baseline or plan to receive any vaccine during the study period.
- •Patients with a known allergy to human-derived biologics.
- •Patients currently participating in another clinical trial.
- •Patients deemed unsuitable for participation by the investigator for other reasons (e.g., severe psychiatric disorders).
研究者
Zhongming Qiu
Professer
Xinqiao Hospital of Chongqing
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