Severity Factors of Dermatomyositis in the Caribbean Population - DM-ANTILLES

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorCentre Hospitalier Universitaire de la Guadeloupe

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10 Participants
are grouped into 1 trial group
Group A: Patients with dermatomyositis

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed at baseline (diagnosis).

Secondary outcomes

1

Mortality

Number of participants who die from any cause during the follow-up period. Units: Count of participants

Time frame
Assessed over 2 years from the date of dermatomyositis diagnosis
2

Relapse Occurrence

Number of participants experiencing relapse(s) during treatment tapering or after treatment discontinuation. Units: Count of participants

Time frame
Assessed over 2 years from the date of dermatomyositis diagnosis
3

Cancer Occurrence

Number of participants diagnosed with any cancer during the follow-up period. Units: Count of participants

Time frame
Assessed over 2 years from the date of dermatomyositis diagnosis

Other outcomes

Sponsors and contacts

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