Clinical Study Cohort of Idiopathic Inflammatory Myositis

Not yet recruiting

• Conditions: Idiopathic Inflammatory Myopathies
• Interventions: Other: no interventions were involved

• Registration Number: NCT06306547
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-03-09
• Last Update Submitted: 2024-03-09
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Study Start: 2024-04-01
• Primary Completion: 2034-04-01
• Study Completion: 2034-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IMM patients with tumors	no interventions were involved	Patients with IMM will be grouped according to the type of positive myositis-specifc autoantibody,and then again according to whether and what type of tumor they had comorbid.
IMM patients without tumors	no interventions were involved	Patients with IMM will be grouped according to the type of positive myositis-specifc autoantibody,and then again according to whether and what type of tumor they had comorbid.

Primary Outcome Measures

Name	Time	Method
High Resolution Computed Tomography of Chest	three months	High Resolution Computed Tomography of Chest will be used to assess the incidence of interstitial pneumonia.
Cutaneous Disease Area and Severity Index	three months	Cutaneous Disease Area and Severity Index will be used to assess the the severity of the rash.
Forced vital capacity	three months	t refers to the maximum amount of air that cr trying to inhale as quickly as possible.
Manual Muscle Testing	three months	Manual Muscle Testing will be used to assess patients with muscle weakness.
Forced expiratory volume in one second	three months	It refers to the volume of the maximum exhalation exhaled in the first second of the maximum deep inhalation.

Secondary Outcome Measures

Name	Time	Method
Serum creatine kinase	three months	Serum creatine kinase will be used to assess the disease activity in idiopathic inflammatory myopathies.