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3T Therapy in the Treatment of MDA5-positive Dermatomyositis

NCT06438679 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2024-06-03

No results posted yet for this study

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

DRUG

Tofacitinib 5 MG

Tofacitinib 5mg BID+thalidomide 50mg BID+tacrolimus 0.1mg/kg QD per oral

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-19
Primary Completion
2024-09-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06438679 on ClinicalTrials.gov