Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04747652 |
| Other study ID # |
MSG-jiangsu |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
June 2021 |
| Source |
The First Affiliated Hospital with Nanjing Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
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.
MSG-Jiangsu, short for Myositis Study Group-Jiangsu, was founded by department of
rheumatology and immunology of eighteen tertiary hospitals. Clinical Research on Advanced
Warning Factors Of Respiratory Injury in Dermatomyositis (CRAWFORD) as a multicenter
observational cohort study was started at Jun 1, 2020. Our cohort plan to recruit 1,000 adult
inpatients. What's more, prognostic data from these DM patients were obtained by following up
for 1 year. At the same time, clinical data and auxiliary examination results of the baseline
DM patients were analyzed to look for factors that are associated with outcomes. Then,
regression analysis of influencing factors will help us to set up a multi-factor weighted
score to forecast the prognosis of DM patients. Finally, Biological specimen from patients at
baseline are used to look for biomarkers that predict prognosis by RNA-sequencing, whole exon
sequencing, proteomic screening and so on.
