3T Therapy in the Treatment of MDA5-positive Dermatomyositis

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT06438679
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Dermatomyositis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib 5 MG — DRUG
    Tofacitinib 5mg BID+thalidomide 50mg BID+tacrolimus 0.1mg/kg QD per oral

Study Details

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

Key Dates

Start date
Mar 19, 2024
Status verified
Feb 2024
Primary completion
Sep 30, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
133 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 3T therapy arm
    This is a single arm experiment

Primary Outcome Measure

Overall survival rate [ Time Frame: 26 weeks ]

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