DermatomyositisJADENCT06004817
Evaluation of Severity in Juvenile and Adult-onset Dermatomyositis
An observational study of Dermatomyositis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Dermatomyositis (DM) are rare and heterogeneous systemic autoimmune diseases, characterized by the association of muscle inflammation, skin inflammation and vasculopathy. DM concern both adults and children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- evaluation of clinical severity
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to 30 Sep 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients followed in pediatric and adult units during January 2010 and December 2022
Who may be able to join
- Patient with dermatomyositis according to 2017 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification
Who cannot join
- Patient with cancer-associated dermatomyositis (within 3 years before or after diagnosis of dermatomyositis)
- Patient with antisynthetase syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Severity in Juvenile Dermatomyositis and Adult-onset Dermatomyositis: a National Multicentric Retrospective Study
Dermatomyositis (DM) are rare and heterogeneous systemic autoimmune diseases, characterized by the association of muscle inflammation, skin inflammation and vasculopathy. DM concern both adults and children. DM can be life-threatening (interstitial lung disease, infectious complications) and responsible of significant functional disability (muscle weakness). Age of onset appear to be an independent prognostic factor. Juvenile-onset DM is characterized by a higher frequency of calcinosis, skin ulceration and digestive vasculitis. In adults, interstitial lung disease and cancer are more frequent with higher mortality. Data concerning the comparison of the initial severity between juvenile and adult-onset DM are limited.
The main objective is to compare global severity between juvenile DM and adult-onset DM at initial diagnosis.
Read more
Secondary objectives are:
- to compare organ-specific severity between juvenile DM and adult-onset DM at diagnosis.
- to compare damage during follow-up and at last follow-up between juvenile DM and adult-onset DM.
- to compare activity at the last follow-up between juvenile DM and adult-onset DM.
- to compare iatrogenic complications between juvenile DM and adult-onset DM.
- Conditions
- Dermatomyositis
- Being tested
- evaluation of clinical severity
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of clinical severityOther
evaluation of clinical severity
| Study group | Role | What they receive |
|---|---|---|
| Juvenile dermatomyositis | Dermatomyositis before 18 years-old Receives: Other: evaluation of clinical severity | |
| Adult-onset dermatomyositis | Dermatomyositis from 18 years-old Receives: Other: evaluation of clinical severity |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with global severity
presence of at least one criteria among: severe muscle disease (Childhood Myositis Assessment Scale
- CMAS - score < 15, and/or Manual Muscle Testing 8 - MMT8 - score < 30, and/or Medical Research Council - MRC - muscle testing < 3, and/or dysphagia and/or swallowing difficulties), symptomatic interstitial lung disease (ILD), digestive vasculitis (digestive bleeding and/or vasculitis on CT-scan), myocarditis on cardiac MRI, severe skin ulcerations, intensive care unit admission
Measured: baseline (J0)
Secondary outcomes (7)
number of patients with muscular severity
presence of at least one of the following criteria: CMAS score < 15, MMT8 score < 30, MRC muscle testing < 3, dysphagia, swallowing difficulties
Measured: baseline (J0)
number of patients with pulmonary severity
presence of symptomatic ILD
Measured: baseline (J0)
number of patients with digestive severity
presence of digestive vasculitis: digestive bleeding and/or vasculitis on CT-scan
Measured: baseline (J0)
number of patients with cutaneous severity
presence of severe skin ulcerations
Measured: baseline (J0)
myositis damage index (MDI) score
myositis damage index (MDI) extent of damage score: from 0 (better outcome) to 38 (worse outcome)
Measured: 2 years of follow-up, at 5 years of follow-up and at last follow-up
number of patients with remission at last follow-up
absence of disease activity without any immunosuppressive/immunomodulatory treatment for at least 2 years
Measured: up to 10 years
number of patients with disease activity at last follow-up
presence of at least one of the following criteria: elevated creatinine kinase (CK) level and/or recent muscle testing deterioration and/or muscle inflammation on MRI, and/or skin manifestations and/or progressive ILD
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul DECKER, MD, Central Hospital, Nancy, France
- Investigators
- Paul Decker, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004817
- Sponsor's protocol ID
- 2023PI150
- Acronym
- JADE
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Severity in Juvenile Dermatomyositis and Adult-onset Dermatomyositis: a National Multicentric Retrospective Study
- ClinicalTrials.gov ID
- NCT06004817
- Acronym / sponsor ID
- JADE / 2023PI150
- Conditions
- Dermatomyositis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 Aug 2023 (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) are rare and heterogeneous systemic autoimmune diseases, characterized by the association of muscle inflammation, skin inflammation and vasculopathy. DM concern both adults and children. DM can be life-threatening (interstitial lung disease, infectious complications) and responsible of significant functional disability (muscle weakness). Age of onset appear to be an independent prognostic factor. Juvenile-onset DM is characterized by a higher frequency of calcinosis, skin ulceration and digestive vasculitis. In adults, interstitial lung disease and cancer are more frequent with higher mortality. Data concerning the comparison of the initial severity between juvenile and adult-onset DM are limited.
The main objective is to compare global severity between juvenile DM and adult-onset DM at initial diagnosis.
Secondary objectives are:
- to compare organ-specific severity between juvenile DM and adult-onset DM at diagnosis.
- to compare damage during follow-up and at last follow-up between juvenile DM and adult-onset DM.
- to compare activity at the last follow-up between juvenile DM and adult-onset DM.
- to compare iatrogenic complications between juvenile DM and adult-onset DM.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Juvenile dermatomyositis | – | Other: evaluation of clinical severityDermatomyositis before 18 years-old |
| Adult-onset dermatomyositis | – | Other: evaluation of clinical severityDermatomyositis from 18 years-old |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients followed in pediatric and adult units during January 2010 and December 2022
Key inclusion criteria (1 listed)
- Patient with dermatomyositis according to 2017 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification
Key exclusion criteria (2 listed)
- Patient with cancer-associated dermatomyositis (within 3 years before or after diagnosis of dermatomyositis)
- Patient with antisynthetase syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of clinical severityevaluation of clinical severity | Other | Adult-onset dermatomyositis, Juvenile dermatomyositis |
Primary outcome
number of patients with global severity
Time frame: baseline (J0)
presence of at least one criteria among: severe muscle disease (Childhood Myositis Assessment Scale - CMAS - score < 15, and/or Manual Muscle Testing 8 - MMT8 - score < 30, and/or Medical Research Council - MRC - muscle testing < 3, and/or dysphagia and/or swallowing difficulties), symptomatic interstitial lung disease (ILD), digestive vasculitis (digestive bleeding and/or vasculitis on CT-scan), myocarditis on cardiac MRI, severe skin ulcerations, intensive care unit admission
7 secondary outcomes
number of patients with muscular severity
Time frame: baseline (J0)
number of patients with pulmonary severity
Time frame: baseline (J0)
number of patients with digestive severity
Time frame: baseline (J0)
number of patients with cutaneous severity
Time frame: baseline (J0)
myositis damage index (MDI) score
Time frame: 2 years of follow-up, at 5 years of follow-up and at last follow-up
number of patients with remission at last follow-up
Time frame: up to 10 years
number of patients with disease activity at last follow-up
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Paul Decker, MD principal investigator
Central Hospital, Nancy, France
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, run by Central Hospital, Nancy, France at 1 site in France.
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 2 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 27 Aug 2024. 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 France. 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?
Contact Paul Decker, MD (+33383157240, p.decker@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with global severity (time frame: baseline (J0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2024.