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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07265999
Acronym
DM-ANTILLES
Enrollment
10
Registered
2025-12-05
Start date
2021-07-16
Completion date
2029-07-16
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatomyositis

Keywords

Dermatomyositis

Brief summary

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.

Detailed description

In the French West Indies, this condition is associated with high short- and medium-term morbidity and mortality. Diagnostic delays and patient care pathways may help explain this. However, a particularly severe phenotype of the disease in Antillean patients may also play a role, as observed in other autoimmune and inflammatory diseases we have described in overseas populations (e.g., systemic sclerosis, sarcoidosis). Identifying factors associated with the severity of dermatomyositis at the time of diagnosis would allow for the early implementation of a tailored management strategy to improve the disease prognosis in the target population.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de la Guadeloupe
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 * Patient (or legal representative) who has received information about the study and has signed the informed consent form * Patient affiliated with a social security scheme

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
severity of dermatomyositis at diagnosisAssessed at baseline (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

MeasureTime frameDescription
MortalityAssessed over 2 years from the date of dermatomyositis diagnosisNumber of participants who die from any cause during the follow-up period. Units: Count of participants
Relapse OccurrenceAssessed over 2 years from the date of dermatomyositis diagnosisNumber of participants experiencing relapse(s) during treatment tapering or after treatment discontinuation. Units: Count of participants
Cancer OccurrenceAssessed over 2 years from the date of dermatomyositis diagnosisNumber of participants diagnosed with any cancer during the follow-up period. Units: Count of participants

Countries

Guadeloupe

Contacts

Primary Contactmelanie petapermal, Master degree
melanie.petapermal@chu-guadeloupe.fr+590590934667
Backup ContactValérie Hamony Soter
valerie.soter@chu-guadeloupe.fr+590590934677

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026