Efficacy and Safety of Triple Therapy in Patients With An... | NCT05375435

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

NCT05375435

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Unknown status

Last Update Posted

May 26, 2022Actual

Enrollment

120Estimated

Phase

Phase 4

Conditions

Dermatomyositis, Adult Type
Interstitial Lung Disease

Interventions

triple therapy
dual-therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

May 11, 2022

First Submission Date that Met QC Criteria

May 11, 2022

First Posted Date

May 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2022

Last Update Posted Date

May 26, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wenfeng Tan, Chief Physician, The First Affiliated Hospital with Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital with Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group	Experimental		Drug: triple therapy
control group	Experimental		Drug: dual-therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
triple therapy	Drug	high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor	experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RPILD	Incidence of RP-ILD in patients after 6 months of treatment	6 months
Death	Mortality rate in patients after 6 months of treatment	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital with Nanjing Medical University	Recruiting	Nanjing	Jiangsu	210029	China

Condition Browse Module

MeSH Terms

ID	Term
D003882	Dermatomyositis
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D017285	Polymyositis
D009220	Myositis
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000080903	Dual Anti-Platelet Therapy

Ancestor Terms

ID	Term
D004359	Drug Therapy, Combination
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided