NCT05375435

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatomyositis, Adult Type
• Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	triple therapy	high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor
DRUG	dual-therapy	high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-05-16
• Last updated: 2022-05-26

Locations

1 site across 1 country: China