About this trial
Dermatomyositis is a rare chronic autoimmune and inflammatory disease that affects the skin and striated muscles. Its prognosis is linked to visceral involvement (lungs, heart, and oropharyngeal region) and to the possible presence of associated cancer. The implementation of the research will allow identification of incident cases of dermatomyositis in Guadeloupe and the characterization of the disease in the overseas population, in the absence of data in the literature.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with a diagnosis of dermatomyositis according to the 2003 ENMC criteria
Patient with parents or grandparents originating from the Caribbean arc
Patient aged 16 years or older
Patient residing in Guadeloupe
Disqualifiers
Patient who started treatment with intravenous immunoglobulins, corticosteroids, or immunosuppressants within the month prior to the diagnosis of dermatomyositis
Patient under legal protection (guardianship or trusteeship) or deprived of liberty
Trial population
The study population consists of patients (\>16 years old) diagnosed with dermatomyositis, including both classic dermatomyositis and clinically amyopathic dermatomyositis, regardless of sex or ethnicity. Eligible patients are those who have received a new diagnosis and can be followed for at least two years.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
severity of dermatomyositis at diagnosis
The primary outcome measure is the severity of dermatomyositis at diagnosis, defined by the presence of one or more of the following criteria: Muscle involvement resulting in functional disability; Associated visceral involvement, including the heart, lungs, or oropharyngeal region; Associated cancer, either previously diagnosed within the past three years or diagnosed concurrently with dermatomyositis.
Secondary outcomes
Mortality
Number of participants who die from any cause during the follow-up period. Units: Count of participants
Relapse Occurrence
Number of participants experiencing relapse(s) during treatment tapering or after treatment discontinuation. Units: Count of participants
Cancer Occurrence
Number of participants diagnosed with any cancer during the follow-up period. Units: Count of participants
Sponsors and contacts
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