NCT06438679Enrolling By Invitation4 期
A Single-centric Prospective Single-arm Study of 3T Therapy in the Treatment of MDA5-positive Dermatomyositis
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2024年3月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
The goal of this clinical trial is to learn if a combination of tacrolimus, tafocitinib and thalidomide (3T therapy) works to treat severe MDA5 positive dermatomyositis in adults. It will also learn about the safety of 3T therapy. The main questions it aims to answer are:
Does 3T therapy prolong the overall survival time of MDA5 positive dermatomyositis? What medical problems do participants have when taking 3T therapy?
Participants will:
Take 3T therapy every day for 12 months Visit the clinic once every 2 weeks for checkups and tests
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or above at the time of screening
- •Diagnosis of MDA5-positive dermatomyositis (EULAR/ACR) during screening, and the following 3 items are met at the same time:
- •The MDA5 titer during screening is ++ or +++;
- •Mild or above decrease in pulmonary diffusing function at screening and baseline;
- •Interstitial extravasation seen on chest CT at screening and baseline
- •Agree to receive highly effective contraception or sterilized
- •Subjects are willing and able to comply with study visits and related procedures
- •Subjects have the ability to understand the research requirements and procedures, voluntarily participate in clinical trials and sign the ICF
排除标准
- •Have received any drug in 3T treatment in the past, but had poor response (including treatment failure or unacceptable treatment-related adverse reactions)
- •Have received lenalidomide, cyclosporine, or other highly selective or pan-selective JAK inhibitors such as lenalidomide or cyclosporine or other highly selective or pan-selective JAK inhibitors such as baricitinib within 2 weeks before visit D1 or within 5 drug half-lives (if known) agent.
- •Have received treatment with an immune cell depleting agent (such as rituximab) within 6 months before the D1 visit.
- •Have received any investigational drug/treatment within 4 weeks or 5 drug half-lives (if known) before visit D1, whichever is longer.
- •Known or suspected history of immunosuppression/deficiency (including but not limited to invasive opportunistic infections such as aspergillosis, coccidioidomycosis, histoplasmosis, AIDS, listeriosis, even if the infection has resolved) within 6 months prior to visit D1, or there are unusually frequent recurring or persistent infections.
- •There is a history of malignant tumors within 5 years before the D1 visit (except for completely cured cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma or thyroid malignant tumors or other malignant tumors considered by the researcher to be amenable to 3T treatment).
- •Positive hepatitis B surface antigen (HBsAg) during screening; or positive hepatitis B core antibody (HBcAb) and positive HBV-DNA; or positive hepatitis C antibody and positive HCV ribonucleic acid (RNA) polymerase chain reaction; or human immune HIV-deficiency virus (HIV) serology was positive.
- •Subjects with active tuberculosis, latent tuberculosis, or a history of non-tuberculous mycobacterial infection at the time of screening.
- •Have a history of systemic hypersensitivity reaction to any drug or matrix or excipient in 3T therapy.
- •Have been vaccinated within 12 weeks before the D1 visit, or plan to receive a live (attenuated) vaccine during the study.
- •Pregnant or lactating women, or subjects who plan to become pregnant or lactating during the study.
- •Any other circumstances in which the researcher determines that it is not appropriate to participate in this study
研究组 & 干预措施
3T therapy arm
Experimental
This is a single arm experiment
干预措施: Tofacitinib 5 MG (Drug)
结局指标
主要结局
Overall survival rate
时间窗: 26 weeks
The overall survival rate at the end of observation
Overall TE incidence
时间窗: 26 weeks
The overall treatment associated adverse effects incidence during the clinical trial
次要结局
未报告次要终点
研究者
研究点 (1)
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