Clinical Study Cohort of Idiopathic Inflammatory Myositis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: no interventions were involved.
- Who it may be relevant to
- Registry conditions: Idiopathic Inflammatory Myopathies. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other no interventions were involved
no interventions were involved
Primary outcome measures
- High Resolution Computed Tomography of Chest [Time frame: three months]
- Cutaneous Disease Area and Severity Index [Time frame: three months]
- Forced vital capacity [Time frame: three months]
- Manual Muscle Testing [Time frame: three months]
- Forced expiratory volume in one second [Time frame: three months]
Secondary outcome measures (1)
- Serum creatine kinase [Time frame: three months]
Eligibility criteria
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:
- 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.
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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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Fu Y, Chen Z, Chen J, Wu W, Gu L, Ma Y, Wang R, Wang K, Xie C, Chen Y, Cai J, Fu Q, Wang X, Ye S. Efficacy of JAK inhibitor combined with protein A immunoadsorption in MDA5+ dermatomyositis with RPILD: A real-world study. Med. 2025 Oct 10;6(10):100802. doi: 10.1016/j.medj.2025.100802. Epub 2025 Sep 8. PMID 40925379
Identifiers
NCT: NCT06306547 · IIM001