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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05375435

Enrollment

120

Registered

2022-05-16

Start date

2022-01-01

Completion date

2024-12-31

Last updated

2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatomyositis, Adult Type, Interstitial Lung Disease

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.

Interventions

DRUGtriple therapy

high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor

DRUGdual-therapy

high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026