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Clinical Study Cohort of Idiopathic Inflammatory Myositis

Clinical Study Cohort of Idiopathic Inflammatory Myositis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06306547
Enrollment
1000
Registered
2024-03-12
Start date
2024-04-01
Completion date
2034-04-01
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Inflammatory Myopathies

Brief summary

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.

Interventions

OTHERno interventions were involved

no interventions were involved

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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: 1. Age≥ 18 years old and ≤ 75 years old 2. 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 3. Cooperate with follow-up, examination and treatment and voluntarily sign the informed consent form. \-

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. \-

Design outcomes

Primary

MeasureTime frameDescription
High Resolution Computed Tomography of Chestthree monthsHigh Resolution Computed Tomography of Chest will be used to assess the incidence of interstitial pneumonia.
Cutaneous Disease Area and Severity Indexthree monthsCutaneous Disease Area and Severity Index will be used to assess the the severity of the rash.
Forced vital capacitythree monthst refers to the maximum amount of air that cr trying to inhale as quickly as possible.
Manual Muscle Testingthree monthsManual Muscle Testing will be used to assess patients with muscle weakness.
Forced expiratory volume in one secondthree monthsIt refers to the volume of the maximum exhalation exhaled in the first second of the maximum deep inhalation.

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026