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Recruiting NCT07265999

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

Observational 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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dermatomyositis. Basic parameters: from 16 years · 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
Guadeloupe
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • severity of dermatomyositis at diagnosis [Time frame: Assessed at baseline (diagnosis).]
Secondary outcome measures (3)
  • Mortality [Time frame: Assessed over 2 years from the date of dermatomyositis diagnosis]
  • Relapse Occurrence [Time frame: Assessed over 2 years from the date of dermatomyositis diagnosis]
  • Cancer Occurrence [Time frame: Assessed over 2 years from the date of dermatomyositis diagnosis]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Guadeloupe · 1 center
  • CHU de la Guadeloupe — Pointe-à-Pitre

Identifiers

NCT: NCT07265999 · PAP_RIPH3_2020/11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗