Evaluation of Severity in Juvenile and Adult-onset Dermatomyositis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: evaluation of clinical severity.
- Who it may be relevant to
- Registry conditions: Dermatomyositis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Severity in Juvenile Dermatomyositis and Adult-onset Dermatomyositis: a National Multicentric Retrospective Study
Overview
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.
Interventions
- Other evaluation of clinical severity
evaluation of clinical severity
Primary outcome measures
- number of patients with global severity [Time frame: baseline (J0)]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- Patient with dermatomyositis according to 2017 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification
Exclusion criteria
- Patient with cancer-associated dermatomyositis (within 3 years before or after diagnosis of dermatomyositis)
- Patient with antisynthetase syndrome
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Chu Nancy — Nancy
Identifiers
NCT: NCT06004817 · 2023PI150