Clinical Study Cohort of Idiopathic Inflammatory Myositis

NCT ID: NCT06306547

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2034-04-01

Brief Summary

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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

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Conditions

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Idiopathic Inflammatory Myopathies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

no interventions were involved

Intervention Type OTHER

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.

no interventions were involved

Intervention Type OTHER

no interventions were involved

Interventions

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no interventions were involved

no interventions were involved

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qiong Fu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IIM001

Identifier Type: -

Identifier Source: org_study_id

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