Evaluation of Severity in Juvenile and Adult-onset Dermatomyositis

NCT ID: NCT06004817

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-09-30

Brief Summary

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Dermatomyositis (DM) are rare and heterogeneous systemic autoimmune diseases, characterized by the association of muscle inflammation, skin inflammation and vasculopathy. DM concern both adults and children. DM can be life-threatening (interstitial lung disease, infectious complications) and responsible of significant functional disability (muscle weakness). Age of onset appear to be an independent prognostic factor. Juvenile-onset DM is characterized by a higher frequency of calcinosis, skin ulceration and digestive vasculitis. In adults, interstitial lung disease and cancer are more frequent with higher mortality. Data concerning the comparison of the initial severity between juvenile and adult-onset DM are limited.

The main objective is to compare global severity between juvenile DM and adult-onset DM at initial diagnosis.

Secondary objectives are:

* to compare organ-specific severity between juvenile DM and adult-onset DM at diagnosis.
* to compare damage during follow-up and at last follow-up between juvenile DM and adult-onset DM.
* to compare activity at the last follow-up between juvenile DM and adult-onset DM.
* to compare iatrogenic complications between juvenile DM and adult-onset DM.

Detailed Description

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Conditions

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Dermatomyositis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Juvenile dermatomyositis

Dermatomyositis before 18 years-old

evaluation of clinical severity

Intervention Type OTHER

evaluation of clinical severity

Adult-onset dermatomyositis

Dermatomyositis from 18 years-old

evaluation of clinical severity

Intervention Type OTHER

evaluation of clinical severity

Interventions

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evaluation of clinical severity

evaluation of clinical severity

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient with dermatomyositis according to 2017 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification

Exclusion Criteria

* Patient with cancer-associated dermatomyositis (within 3 years before or after diagnosis of dermatomyositis)
* Patient with antisynthetase syndrome
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Paul DECKER, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Decker, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NANCY

Locations

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Chu Nancy

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Paul Decker, MD

Role: CONTACT

+33383157240

Facility Contacts

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Paul DECKER, MD

Role: primary

Other Identifiers

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2023PI150

Identifier Type: -

Identifier Source: org_study_id

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