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NCT Number: NCT07265999

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de la Guadeloupe

Pointe-à-Pitre, 97139, Guadeloupe

Location status: Recruiting

Location contact

nadège cordel, MD PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. severity of dermatomyositis at diagnosis

    Time frame: Assessed 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 outcomes

  1. Mortality

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

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

    Units: Count of participants

  2. Relapse Occurrence

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

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

    Units: Count of participants

  3. Cancer Occurrence

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

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

    Units: Count of participants

Study contacts

Contact information is provided by the study sponsor or research team.

Valérie Hamony Soter

CONTACT

[email protected]

+590590934677

melanie petapermal, Master degree

CONTACT

[email protected]

+590590934667

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Other

Registry information

Acronym: DM-ANTILLES

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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