Clinical Study Cohort of Idiopathic Inflammatory Myositis

Idiopathic Inflammatory Myopathies Clinical Trial

Official title:

Clinical Study Cohort of Idiopathic Inflammatory Myositis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06306547
• Other study ID #: IIM001
• Status: Not yet recruiting
• 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
• 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.

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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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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