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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06306547
Other study ID # IIM001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2034

Study information

Verified date February 2024
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date April 1, 2034
Est. primary completion date April 1, 2034
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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. -

Study Design


Related Conditions & MeSH terms

  • Idiopathic Inflammatory Myopathies
  • Myositis

Intervention

Other:
no interventions were involved
no interventions were involved

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary High Resolution Computed Tomography of Chest High Resolution Computed Tomography of Chest will be used to assess the incidence of interstitial pneumonia. three months
Primary Cutaneous Disease Area and Severity Index Cutaneous Disease Area and Severity Index will be used to assess the the severity of the rash. three months
Primary Forced vital capacity t refers to the maximum amount of air that cr trying to inhale as quickly as possible. three months
Primary Manual Muscle Testing Manual Muscle Testing will be used to assess patients with muscle weakness. three months
Primary Forced expiratory volume in one second It refers to the volume of the maximum exhalation exhaled in the first second of the maximum deep inhalation. three months
Secondary Serum creatine kinase Serum creatine kinase will be used to assess the disease activity in idiopathic inflammatory myopathies. three months
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