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NCT05375435 Clinical Trial

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

Interstitial Lung Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05375435
Other study ID # TT-MDA5
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2024

Study information
Verified date May 2022
Source The First Affiliated Hospital with Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• triple therapy
high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor
• dual-therapy
high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor

Locations
Country Name City State
China The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary RPILD Incidence of RP-ILD in patients after 6 months of treatment 6 months
Primary Death Mortality rate in patients after 6 months of treatment 6 months
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