NCT06438679

3T Therapy in the Treatment of MDA5-positive Dermatomyositis

A Single-centric Prospective Single-arm Study of 3T Therapy in the Treatment of MDA5-positive Dermatomyositis

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 133 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dermatomyositis

Interventions

Type	Name	Description
DRUG	Tofacitinib 5 MG	Tofacitinib 5mg BID+thalidomide 50mg BID+tacrolimus 0.1mg/kg QD per oral

Timeline

• Start date: 2024-03-19
• Primary completion: 2024-09-01
• Completion: 2026-12-01
• First posted: 2024-06-03
• Last updated: 2024-06-03

Locations

1 site across 1 country: China