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

Last updated: May 20, 2022
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting

Phase

4

Condition

Lung Disease

Lupus

Connective Tissue Diseases

Treatment

N/A

Clinical Study ID

NCT05375435
TT-MDA5
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 120
Study Start date:
January 01, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

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