Idiopathic Inflammatory MyopathiesNCT06306547
Clinical Study Cohort of Idiopathic Inflammatory Myositis
An observational study of Idiopathic Inflammatory Myopathies, run by RenJi Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Inflammatory Myopathies
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2034
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Aged 18-75 years and eligible for the 2017 European League Against Rheumatism/American College of Rheumatology.
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. - Exclusion Criteria:Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:
- 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. -
About this study
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
- Being tested
- no interventions were involved
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventions were involvedOther
no interventions were involved
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: no interventions were involved |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Resolution Computed Tomography of Chest
High Resolution Computed Tomography of Chest will be used to assess the incidence of interstitial pneumonia.
Measured: 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.
Measured: three months
Forced vital capacity
t refers to the maximum amount of air that cr trying to inhale as quickly as possible.
Measured: three months
Manual Muscle Testing
Manual Muscle Testing will be used to assess patients with muscle weakness.
Measured: 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.
Measured: three months
Secondary outcomes (1)
Serum creatine kinase
Serum creatine kinase will be used to assess the disease activity in idiopathic inflammatory myopathies.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2034 (estimated)
- Study completion1 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Inflammatory MyopathiesStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiong Fu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306547
- Sponsor's protocol ID
- IIM001
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40925379
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Cohort of Idiopathic Inflammatory Myositis
- ClinicalTrials.gov ID
- NCT06306547
- Acronym / sponsor ID
- IIM001
- Conditions
- Idiopathic Inflammatory Myopathies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2034 (estimated)
- Study completion
- 1 Apr 2034 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMM patients with tumors | – | Other: no interventions were involvedPatients 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. |
| IMM patients without tumors | – | Other: no interventions were involvedPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aged 18-75 years and eligible for the 2017 European League Against Rheumatism/American College of Rheumatology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventions were involvedno interventions were involved | Other | IMM patients with tumors, IMM patients without tumors |
Primary outcome
High Resolution Computed Tomography of Chest
Time frame: three months
High Resolution Computed Tomography of Chest will be used to assess the incidence of interstitial pneumonia.
Cutaneous Disease Area and Severity Index
Time frame: three months
Cutaneous Disease Area and Severity Index will be used to assess the the severity of the rash.
Forced vital capacity
Time frame: three months
t refers to the maximum amount of air that cr trying to inhale as quickly as possible.
Manual Muscle Testing
Time frame: three months
Manual Muscle Testing will be used to assess patients with muscle weakness.
Forced expiratory volume in one second
Time frame: three months
It refers to the volume of the maximum exhalation exhaled in the first second of the maximum deep inhalation.
1 secondary outcome
Serum creatine kinase
Time frame: three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 40925379Fu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Inflammatory Myopathies, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Resolution Computed Tomography of Chest (time frame: three months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06306547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.