Back to resultsEfficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis
Primary Purpose
Dermatomyositis, Adult Type, Interstitial Lung Disease
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
triple therapy
dual-therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dermatomyositis, Adult Type
Eligibility Criteria
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
Sites / Locations
- The First Affiliated Hospital with Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
experimental group
control group
Arm Description
Outcomes
Primary Outcome Measures
RPILD
Incidence of RP-ILD in patients after 6 months of treatment
Death
Mortality rate in patients after 6 months of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT05375435
First Posted
May 11, 2022
Last Updated
May 20, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05375435
Brief Title
Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatomyositis, Adult Type, Interstitial Lung Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Title
control group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
triple therapy
Intervention Description
high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor
Intervention Type
Drug
Intervention Name(s)
dual-therapy
Intervention Description
high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor
Primary Outcome Measure Information:
Title
RPILD
Description
Incidence of RP-ILD in patients after 6 months of treatment
Time Frame
6 months
Title
Death
Description
Mortality rate in patients after 6 months of treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenfeng Tan, PhD, MD
Phone
086 18061202878
Email
tanwenfeng@jsph.org.cn
First Name & Middle Initial & Last Name & Degree
Hanxiao You, PhD, MD
Phone
086 18800181269
Email
youhanxiao@jsph.org.cn
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis
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