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NCT Number: NCT06306547

Clinical Study Cohort of Idiopathic Inflammatory Myositis

Idiopathic inflammatory myositis (IIM), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment responses, and prognosis. This project will build a clinical follow-up cohort for idiopathic inflammatory myositis (IIM) centered on Renji Hospital, Shanghai Jiao Tong University School of Medicine, to promote the clinical and pathogenesis of this group of diseases.

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Key information

Conditions

Idiopathic Inflammatory Myopathies Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects must meet the following criteria for inclusion in this study: meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (IIM) or the 2018 ENMC-DM classification criteria (see above), plus:

  • Age≥ 18 years old and ≤ 75 years old
  • Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (IIM), the above score ≥ 5.5 points if there is no muscle biopsy, and 6.7 points ≥ if there is muscle biopsy
  • Cooperate with follow-up, examination and treatment and voluntarily sign the informed consent form.

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Exclusion criteria

Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:

a. IIM with other connective tissue diseases; b. Negative myositis antibody test; c. Those who are in the period of acute infection, or have a history of active tuberculosis in the past; d. People with allergies or allergies to multiple drugs; e. Those who have mental illness or other reasons and cannot cooperate with examination, follow-up or treatment; f. Women who are pregnant, or are trying to become pregnant; g. Those who are participating in or have participated in clinical trials within the specified time.

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Treatment and study plan

no interventions were involved

Other

no interventions were involved

Primary outcomes

  1. High Resolution Computed Tomography of Chest

    Time frame: three months

    High Resolution Computed Tomography of Chest will be used to assess the incidence of interstitial pneumonia.

  2. Cutaneous Disease Area and Severity Index

    Time frame: three months

    Cutaneous Disease Area and Severity Index will be used to assess the the severity of the rash.

  3. Forced vital capacity

    Time frame: three months

    t refers to the maximum amount of air that cr trying to inhale as quickly as possible.

  4. Manual Muscle Testing

    Time frame: three months

    Manual Muscle Testing will be used to assess patients with muscle weakness.

  5. Forced expiratory volume in one second

    Time frame: three months

    It refers to the volume of the maximum exhalation exhaled in the first second of the maximum deep inhalation.

Secondary outcomes

  1. Serum creatine kinase

    Time frame: three months

    Serum creatine kinase will be used to assess the disease activity in idiopathic inflammatory myopathies.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Mar 12, 2024
Registry last updated
Mar 12, 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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