NCT04747652

Brief Summary

Dermatomyositis (DM) is a highly heterogeneous autoimmune disease characterized by rash and myasthenia. Beside these, respiratory involvement is one of the common complications of DM. Interstitial lung disease (ILD) occur in approximately 90% of patients with DM, part of them may manifest rapidly progressive-interstitial lung disease (rp-ILD), which progresses into respiratory failure that is difficult to correct and leads to death. Early identification of rp-ILD high risk group is of great significance to improve the prognosis of patients and to conduct following clinical studies. A simple, easy, convenient and reliable diagnostic tool has not yet acquired till now.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

2.6 years

First QC Date

February 7, 2021

Last Update Submit

June 29, 2021

Conditions

Keywords

DermatomyositisRespiratory InjuryAdvanced Warning

Outcome Measures

Primary Outcomes (1)

  • death

    death caused by dermatomyositis and its related complications

    within 12 months after disease oneset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recruit inpatients from department of rheumatology and immunology of eighteen tertiary hospitals in Jiangsu province

You may qualify if:

  • adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter

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

Related Publications (1)

  • Wang L, Lv C, You H, Xu L, Yuan F, Li J, Wu M, Zhou S, Da Z, Qian J, Wei H, Yan W, Zhou L, Wang Y, Yin S, Zhou D, Wu J, Lu Y, Su D, Liu Z, Liu L, Ma L, Xu X, Zang Y, Liu H, Ren T, Liu J, Wang F, Zhang M, Tan W. Rapidly progressive interstitial lung disease risk prediction in anti-MDA5 positive dermatomyositis: the CROSS model. Front Immunol. 2024 Feb 1;15:1286973. doi: 10.3389/fimmu.2024.1286973. eCollection 2024.

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cell, serum or plasma, muscle and lung biopsy specimen

MeSH Terms

Conditions

Dermatomyositis

Condition Hierarchy (Ancestors)

PolymyositisMyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 7, 2021

First Posted

February 10, 2021

Study Start

June 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

July 1, 2021

Record last verified: 2021-06

Locations