NCT03192657

Basiliximab Treating Interstitial Pneumonia of CADM

Basiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a 52-week, randomized, open and routine treatment controlled study. This study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are planned to be enrolled in a single center.

Conditions

• Lung; Disease, Interstitial, With Fibrosis
• Dermatomyositis

Interventions

Type	Name	Description
DRUG	Basiliximab	The first administration should be within 8 weeks after disease onset.
DRUG	Calcineurin Inhibitors	Researchers can choose cyclosporin A or tacrolimus according to patient tolerance. Either agent should be applied promptly once infection is ruled out for a patient.
DRUG	Steroids	Dosage of steroid can be adjusted according to personal experience of the researcher.

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-06-01
• Completion: 2020-06-01
• First posted: 2017-06-20
• Last updated: 2017-06-20

Locations

1 site across 1 country: China