JPRN-jRCTs031220641招募中2 期
Exploratory Study to Evaluate the Efficacy and Safety of Baricitinib in Interstitial Pneumonia Associated with Anti-MDA5 Antibody-Positive Dermatomyositis
Fujio Keishi0 个研究点目标入组 5 人开始时间: 2023年2月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 75age old（—）
- 性别
- All
入选标准
- •1. Those who are positive for anti-MDA5 antibody.
- •2. Those who meet the definition of clinically amyopathic dermatomyositis (CADM) or classical DM proposed by Sontheimer.
- •3. Those who have interstitial pneumonia on chest CT.
- •4. Those who are between 18 and 75 years of age at the time consent is obtained.
- •5. Gender is not required.
- •6. Any immunosuppressive therapy prior to participation in this study is acceptable.
- •7. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study.
- •8. Those who can conduct inspections in accordance with the research implementation schedule.
排除标准
- •1. Those who have serious infection.
- •2. Those who have active tuberculosis.
- •3. Those who have a neutrophil count of less than 500 /mm3.
- •4. Pregnant women or those who may be pregnant.
- •5. Those who are on dialysis or with severe renal insufficiency (eGFR<30 mL/min/1.73m2).
- •6. Those who have a lymphocyte count less than 200 /mm3.
- •7. Those who are positive for HBs antigen or HBV-DNA
- •8. Those who are undergoing treatment for malignancy or have a history of malignancy within 5 years.
- •9. Those who are using a JAK inhibitor other than baricitinib.
- •10. Those who have active thrombosis (within 30 days of onset).
- •11. Those who are judged by clinical research physicians to be inappropriate to participate in this trial by other reasons.
研究者
相似试验
进行中（未招募）
1 期
Exploratory study to evaluate the efficacy and safety of nutritionally administering 1.5 g protein/kg/day vs. 1.0 g protein/kg/day in the catabolic phase of the critically ill patient on mechanical ventilatioAcquired Weakness in the Intensive Care Unit (DAUCI) of the critically ill patient.MedDRA version: 20.0Level: PTClassification code 10077255Term: Intensive care unit acquired weaknessSystem Organ Class: 10029205 - Nervous system disordersEUCTR2021-002329-56-ESSociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)200
招募中
不适用
Exploratory study to evaluate the efficacy and safety of tocilizumab for Takayasu's arteritis based on classification by type of autoantibodyTATakayasu's arteritisJPRN-jRCTs021210077Ishii Tomonori20
尚未招募
不适用
The exploratory study for the efficacy and the safety of Rikkunshito on symptoms of indigestion in the patients with Functional HeartburFunctional HeartburnJPRN-UMIN000029668ippon Medical School Graduate School of Medicine20
已完成
不适用
The exploratory study for the efficacy and the safety of Hangeshashinto on symptoms of heartburn /belch in the patients with gastroesophageal reflux disease (GERD)GERDJPRN-UMIN000021251Osaka Medical College80
已完成
不适用
The exploratory study for the efficacy and the safety of Daikenchuto(TJ-100) on abdominal pain and abdominal fullness feeling in the patients with fecal incontinence.Abdominal pain and abdominal fullness feeling in the patients with fecal incontinenceJPRN-UMIN000030252Medical Corporation Seiaikai, Gion Usshita Hospital50