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

NCT05375435 — Phase 4, Unknown, 120 participants, The First Affiliated Hospital with Nanjing Medical University

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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

Registry	NCT05375435
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	120 (Estimated)
Sponsor	The First Affiliated Hospital with Nanjing Medical University (Other)
Conditions	Dermatomyositis, Adult Type, Interstitial Lung Disease
Interventions	triple therapy, dual-therapy (Drug)
Dates	start 2022-01-01, primary completion 2024-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2022-05-16, last updated 2022-05-26
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
experimental group	Experimental	Drug: triple therapy
control group	Experimental	Drug: dual-therapy

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country	Status
The First Affiliated Hospital with Nanjing Medical University	Nanjing, Jiangsu	China	Recruiting