Methotrexate as the second-line therapY for relapse or inadequate response to Steroid Therapy In patients with Cardiac Sarcoidosis: a multicenter Randomized Controlled Trial - MYSTICS-RCT

Izumi Chisato0 个研究点目标入组 120 人开始时间: 2023年7月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Patients meeting all 5 criteria below:
•Patients who are 18 years of age or older but younger than 90 years of age at the time of obtaining consent.
•Patients who meet the diagnostic criteria for cardiac sarcoidosis in the Japanese guideline.
•Patients who have received treatment with adrenal cortical steroids for more than 24 weeks for cardiac sarcoidosis or have been treated in the past.
•Patients who have demonstrated accumulation indicating activity on F18-fluorodeoxyglucose-positron emission tomography (FDG-PET) or gallium scintigraphy within 2 months prior to obtaining consent for this trial.
•Patients who have provided written consent either by themselves or by a legal representative.

•Patients who meet any of the following criteria are excluded from participation in this study:
•Patients who are intolerant or contraindicated to methotrexate or prednisolone.
•Patients who are receiving medication with methotrexate or other immunosuppressants.
•Patients with poorly controlled diabetes (HbA1c >= 9.0%).
•Pregnant, lactating, or women who are unable to consent to contraception during the trial.
•Men who are unable to consent to contraception during the trial.
•Patients undergoing maintenance hemodialysis.
•Patients who have already participated in other clinical trials or plan to participate during the study period.
•Patients deemed inappropriate for participation in this trial by the study principal investigator or co-investigator for other reasons.

发起方

Izumi Chisato