DermatomyositisCRAWFORDNCT04747652
Clinical Research on Advanced Warning Factors Of Respiratory Injury in Dermatomyositis
An observational study of Dermatomyositis and Respiratory Injury, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatomyositis, Respiratory Injury
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 31 Dec 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruit inpatients from department of rheumatology and immunology of eighteen tertiary hospitals in Jiangsu province
Who may be able to join
- adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Wenfeng Tan, PhD, MD, 086 18061202878, tanwenfeng@jsph.org.cn
Lingxiao Xu, PhD, MD, 086 18020130778, lingxiao32@163.com
About this study
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.
Read the detailed 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.
- Conditions
- Dermatomyositis, Respiratory Injury
- Keywords
- Dermatomyositis, Respiratory Injury, Advanced Warning
- Medical subject headings
- Dermatomyositis
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death caused by dermatomyositis and its related complications
Measured: within 12 months after disease oneset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Jun 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Wenfeng Tan, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747652
- Sponsor's protocol ID
- MSG-jiangsu
- Acronym
- CRAWFORD
- Status last verified
- Jun 2021
- First submitted
- 7 Feb 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38361940
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Advanced Warning Factors Of Respiratory Injury in Dermatomyositis
- ClinicalTrials.gov ID
- NCT04747652
- Acronym / sponsor ID
- CRAWFORD / MSG-jiangsu
- Conditions
- Dermatomyositis, Respiratory Injury
- Keywords
- Dermatomyositis, Respiratory Injury, Advanced Warning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruit inpatients from department of rheumatology and immunology of eighteen tertiary hospitals in Jiangsu province
Key inclusion criteria (1 listed)
- adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death
Time frame: within 12 months after disease oneset
death caused by dermatomyositis and its related complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 38361940Wang 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.
Related trials for Dermatomyositis
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Active, not recruitingPhase 2
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
Dermatomyositis, Myositis
RecruitingObservational study
Natural History of Inflammatory Muscle Diseases
Inflammation In Skeletal Muscle
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
RecruitingPhase 2
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
Dermatomyositis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatomyositis and Respiratory Injury, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: within 12 months after disease oneset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.