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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Inflammatory Myopathies
• Intervention / Treatment: Other: no interventions were involved

• Study Type: Observational
• Enrollment (Estimated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Aged 18-75 years and eligible for the 2017 European League Against Rheumatism/American College of Rheumatology.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IMM patients with tumors; 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.	Other: no interventions were involved; no interventions were involved
IMM patients without tumors; 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.	Other: no interventions were involved; no interventions were involved

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Resolution Computed Tomography of Chest	High Resolution Computed Tomography of Chest will be used to assess the incidence of interstitial pneumonia.	three months
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
Forced vital capacity	t refers to the maximum amount of air that cr trying to inhale as quickly as possible.	three months
Manual Muscle Testing	Manual Muscle Testing will be used to assess patients with muscle weakness.	three months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatine kinase	Serum creatine kinase will be used to assess the disease activity in idiopathic inflammatory myopathies.	three months

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2034
• Study Completion (Estimated): April 1, 2034

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 9, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Myositis
• Other Study ID Numbers: IIM001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No