Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis

May 20, 2022 updated by: Wenfeng Tan, The First Affiliated Hospital with Nanjing Medical University

Efficacy and Safety of Triple Therapy Based on Prognostic Risk Stratification in Patients With Anti-MDA5 Antibody-positive Dermatomyositis: a Multicenter, Prospective, Randomized Controlled Study

We conduct this study to investigate the efficacy of triple therapy (high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor) compared with dual-therapy regimens (high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor) and whether it reduces the risk of poor pulmonary prognosis in patients with moderate to high risk anti-MDA5+ DM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter
  • Anti-MDA5 Antibody-positive

Exclusion Criteria:

  • Complicated with other connective tissue diseases
  • Complicated with cardiovascular and respiratory disease caused by other reasons
  • Interstitial lung disease caused by environment and drugs
  • Patients with key research missing data or without informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Drug: triple therapy
high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor
Experimental: control group
Drug: dual-therapy
high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RPILD
Time Frame: 6 months
Incidence of RP-ILD in patients after 6 months of treatment
6 months
Death
Time Frame: 6 months
Mortality rate in patients after 6 months of treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TT-MDA5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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