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

Nanjing Medical University

Status and phase: Enrolling; Phase 4

Conditions: Dermatomyositis, Adult Type; Interstitial Lung Disease

Treatments: Drug: triple therapy; Drug: dual-therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05375435

TT-MDA5

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

experimental group

Experimental group

Treatment:

Drug: triple therapy

control group

Experimental group

Treatment:

Drug: dual-therapy