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NCT Number: NCT06004817

Evaluation of Severity in Juvenile and Adult-onset Dermatomyositis

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.

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Key information

Conditions

Dermatomyositis Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyositis Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Nancy

Nancy, France

Location status: Recruiting

Location contact

Paul DECKER, MD

CONTACT

Who can participate

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

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

Treatment and study plan

evaluation of clinical severity

Other

evaluation of clinical severity

Primary outcomes

  1. number of patients with global severity

    Time frame: baseline (J0)

    presence of at least one criteria among: severe muscle disease (Childhood Myositis Assessment Scale

    • CMAS - score < 15, and/or Manual Muscle Testing 8 - MMT8 - score < 30, and/or Medical Research Council - MRC - muscle testing < 3, and/or dysphagia and/or swallowing difficulties), symptomatic interstitial lung disease (ILD), digestive vasculitis (digestive bleeding and/or vasculitis on CT-scan), myocarditis on cardiac MRI, severe skin ulcerations, intensive care unit admission

Secondary outcomes

  1. number of patients with muscular severity

    Time frame: baseline (J0)

    presence of at least one of the following criteria: CMAS score < 15, MMT8 score < 30, MRC muscle testing < 3, dysphagia, swallowing difficulties

  2. number of patients with pulmonary severity

    Time frame: baseline (J0)

    presence of symptomatic ILD

  3. number of patients with digestive severity

    Time frame: baseline (J0)

    presence of digestive vasculitis: digestive bleeding and/or vasculitis on CT-scan

  4. number of patients with cutaneous severity

    Time frame: baseline (J0)

    presence of severe skin ulcerations

  5. myositis damage index (MDI) score

    Time frame: 2 years of follow-up, at 5 years of follow-up and at last follow-up

    myositis damage index (MDI) extent of damage score: from 0 (better outcome) to 38 (worse outcome)

  6. number of patients with remission at last follow-up

    Time frame: up to 10 years

    absence of disease activity without any immunosuppressive/immunomodulatory treatment for at least 2 years

  7. number of patients with disease activity at last follow-up

    Time frame: up to 10 years

    presence of at least one of the following criteria: elevated creatinine kinase (CK) level and/or recent muscle testing deterioration and/or muscle inflammation on MRI, and/or skin manifestations and/or progressive ILD

Study contacts

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

Paul Decker, MD

CONTACT

[email protected]

+33383157240

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Evaluation of Severity in Juvenile Dermatomyositis and Adult-onset Dermatomyositis: a National Multicentric Retrospective Study

Acronym: JADE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2023
Registry last updated
Aug 27, 2024

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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