CClinicalTrials.gg
Not yet recruitingNCT06306547Updated Mar 12, 2024

Clinical Study Cohort of Idiopathic Inflammatory Myositis

An observational study in Idiopathic Inflammatory Myopathies, sponsored by RenJi Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Idiopathic Inflammatory Myopathies

Browse trials for

03

In context

Myositis

242 studies on the registry are indexed under Myositis; 103 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 226 across 72 observational studies indexed under Myositis.

Browse Myositis studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.

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:

  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.

    -

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • Otherno interventions were involved

    no interventions were involved

06

What researchers measure

Primary outcomes

  1. High Resolution Computed Tomography of Chest

    High Resolution Computed Tomography of Chest will be used to assess the incidence of interstitial pneumonia.

    Time frame: three months

  2. Cutaneous Disease Area and Severity Index

    Cutaneous Disease Area and Severity Index will be used to assess the the severity of the rash.

    Time frame: three months

  3. Forced vital capacity

    t refers to the maximum amount of air that cr trying to inhale as quickly as possible.

    Time frame: three months

  4. Manual Muscle Testing

    Manual Muscle Testing will be used to assess patients with muscle weakness.

    Time frame: three months

  5. 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.

    Time frame: three months

Secondary outcomes

  1. Serum creatine kinase

    Serum creatine kinase will be used to assess the disease activity in idiopathic inflammatory myopathies.

    Time frame: three months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06306547
Lead sponsor
RenJi Hospital
Responsible party
Qiong Fu (Director, RenJi Hospital) — Principal investigator
First posted
Mar 12, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
Apr 1, 2034 (estimated)
Completion
Apr 1, 2034 (estimated)
Last update
Mar 12, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion