Clinical Study Cohort of Idiopathic Inflammatory Myositis

NCT06306547 | Not Yet Recruiting

• 1 other identifier: IIM001
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Idiopathic Inflammatory Myopathies

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Serum creatine kinase

  three months

Study Arms (2)

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

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

Interventions

no interventions were involved OTHER

no interventions were involved

IMM patients with tumors; IMM patients without tumors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age≥ 18 years old and ≤ 75 years old
• 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
• Cooperate with follow-up, examination and treatment and voluntarily sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Myositis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2034
• Study Completion (Estimated): April 1, 2034
• Last Updated: March 12, 2024

Record last verified: 2024-02