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

The First Affiliated Hospital with Nanjing Medical University120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Dermatomyositis, Adult Type Interstitial Lung Disease

Interventions

triple therapyDRUG

high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor

dual-therapyDRUG

high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

RPILD

Incidence of RP-ILD in patients after 6 months of treatment

Time frame: 6 months

Death

Mortality rate in patients after 6 months of treatment

Time frame: 6 months

Data from ClinicalTrials.gov

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