NCT05375435

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

May 11, 2022

Last Update Submit

May 20, 2022

Conditions

Dermatomyositis, Adult TypeInterstitial Lung Disease

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

experimental group

EXPERIMENTAL
Drug: triple therapy

control group

EXPERIMENTAL
Drug: dual-therapy

Interventions

triple therapyDRUG

high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor

experimental group
dual-therapyDRUG

high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter
  • Anti-MDA5 Antibody-positive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

DermatomyositisLung Diseases, Interstitial

Interventions

Dual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

PolymyositisMyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, CombinationDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 16, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

CN(1)