drugset / Trial / NCT06438679

3T Therapy in the Treatment of MDA5-positive Dermatomyositis

NCT06438679

Phase 4 Enrolling by invitation 133 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2024-03-19
Primary completion
2024-09
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule 0.1 mg/kg Oral
Subject Thalidomide Other / unclassified 50 mg Oral
Subject Tofacitinib Small molecule 5 mg Oral

Indications