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

Phase 4

Recruiting

• Conditions: Dermatomyositis, Adult Type; Interstitial Lung Disease
• Interventions: Drug: triple therapy; Drug: dual-therapy

• Registration Number: NCT05375435
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-16
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	triple therapy	-
control group	dual-therapy	-

Primary Outcome Measures

Name	Time	Method
RPILD	6 months	Incidence of RP-ILD in patients after 6 months of treatment
Death	6 months	Mortality rate in patients after 6 months of treatment

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China