DermatomyositisDM-ANTILLESNCT07265999
Severity Factors of Dermatomyositis in the Caribbean Population - DM-ANTILLES
An observational study of Dermatomyositis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dermatomyositis
- How many people
- 10 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 16 Jul 2021to 16 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU de la Guadeloupe
Pointe-à-Pitre, 97139
nadège cordel, MD PhD, nadege.cordel@chu-guadeloupe.fr
About this study
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.
Read the 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.
- Conditions
- Dermatomyositis
- Keywords
- Dermatomyositis
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with dermatomyositis | All patient with dermatomyositis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at baseline (diagnosis).
Secondary outcomes (3)
Mortality
Number of participants who die from any cause during the follow-up period.
Units: Count of participants
Measured: Assessed over 2 years from the date of dermatomyositis diagnosis
Relapse Occurrence
Number of participants experiencing relapse(s) during treatment tapering or after treatment discontinuation.
Units: Count of participants
Measured: Assessed over 2 years from the date of dermatomyositis diagnosis
Cancer Occurrence
Number of participants diagnosed with any cancer during the follow-up period.
Units: Count of participants
Measured: Assessed over 2 years from the date of dermatomyositis diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start16 Jul 2021
- Primary completion16 Jul 2029 (estimated)
- Study completion16 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- nadège cordel, MD PhD, Principal investigator, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265999
- Sponsor's protocol ID
- PAP_RIPH3_2020/11
- Acronym
- DM-ANTILLES
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severity Factors of Dermatomyositis in the Caribbean Population - DM-ANTILLES
- ClinicalTrials.gov ID
- NCT07265999
- Acronym / sponsor ID
- DM-ANTILLES / PAP_RIPH3_2020/11
- Conditions
- Dermatomyositis
- Keywords
- Dermatomyositis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 16 Jul 2029 (estimated)
- Study completion
- 16 Jul 2029 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with dermatomyositis | – | –All patient with dermatomyositis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
nadège cordel, MD PhD principal investigator
CHU de la Guadeloupe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatomyositis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact melanie petapermal, Master degree (+590590934667, melanie.petapermal@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of dermatomyositis at diagnosis (time frame: Assessed at baseline (diagnosis).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.