Idiopathic Inflammatory MyopathiesMAIANCT04792931
Adult Autoimmune Myopathies (MAIA)
A study testing description of adult autoimmune myopathies in people with Idiopathic Inflammatory Myopathies, run by University Hospital, Brest at 1 site in France.
Trial summary
This study corresponds to a monocentric prospective cohort of adult patients presenting a suspicion of idiopathic inflammatory myopathy. It will allows the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood sample, urine, stool and muscle… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Inflammatory Myopathies
- What is being tested?
- description of adult autoimmune myopathies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2022to 20 May 2030
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion of Adult Inflammatory Myopathy
- Social security affiliation
Who cannot join
- Pregnant and lactating women
- Patients unable to consent
- Patients refusing to participate in the research.
- Patients under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de BREST
Brest, 29200
Dewi GUELLEC, 0230337617, dewi.guellec@chu-brest.fr
About this study
Official title: Adult Autoimmune Myopathies (MAIA): Clinical and Immunological Characterization, Constitution of a Patient Library
This study corresponds to a monocentric prospective cohort of adult patients presenting a suspicion of idiopathic inflammatory myopathy. It will allows the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood sample, urine, stool and muscle specimen.
- Conditions
- Idiopathic Inflammatory Myopathies
- Being tested
- description of adult autoimmune myopathies
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
description of adult autoimmune myopathiesOther
description of adult autoimmune myopathies
| Study group | Role | What they receive |
|---|---|---|
| Adult Autoimmune Myopathies | Other | It is a description Autoimmune Myopathie cohort Receives: Other: description of adult autoimmune myopathies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of lymphocytes subpopulations (B, T and TH-17)
Distribution of lymphocytes subpopulations (B, T and TH-17) according to the final diagnosis defined by a panel of experts
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start20 May 2022
- Primary completion20 May 2030 (estimated)
- Study completion20 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Inflammatory MyopathiesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- diagnosis and follow up of adult autoimmune myopathies
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792931
- Sponsor's protocol ID
- 29BRC20.0276
- Acronym
- MAIA
- Status last verified
- Jun 2026
- First submitted
- 8 Mar 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Autoimmune Myopathies (MAIA): Clinical and Immunological Characterization, Constitution of a Patient Library
- ClinicalTrials.gov ID
- NCT04792931
- Acronym / sponsor ID
- MAIA / 29BRC20.0276
- Conditions
- Idiopathic Inflammatory Myopathies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 20 May 2030 (estimated)
- Study completion
- 20 May 2030 (estimated)
- First posted
- 11 Mar 2021 (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.
This study corresponds to a monocentric prospective cohort of adult patients presenting a suspicion of idiopathic inflammatory myopathy. It will allows the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood sample, urine, stool and muscle specimen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- diagnosis and follow up of adult autoimmune myopathies
| Arm | Type | Receives |
|---|---|---|
| Adult Autoimmune Myopathies | Other | Other: description of adult autoimmune myopathiesIt is a description Autoimmune Myopathie cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical suspicion of Adult Inflammatory Myopathy
- Social security affiliation
Key exclusion criteria (4 listed)
- Pregnant and lactating women
- Patients unable to consent
- Patients refusing to participate in the research.
- Patients under legal protection
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 |
|---|---|---|
| description of adult autoimmune myopathiesdescription of adult autoimmune myopathies | Other | Adult Autoimmune Myopathies |
Primary outcome
Distribution of lymphocytes subpopulations (B, T and TH-17)
Time frame: 6 months
Distribution of lymphocytes subpopulations (B, T and TH-17) according to the final diagnosis defined by a panel of experts
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 25 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing description of adult autoimmune myopathies in people with Idiopathic Inflammatory Myopathies, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Dewi GUELLEC (0230337617, dewi.guellec@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of lymphocytes subpopulations (B, T and TH-17) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.