Back to resultsAdult Autoimmune Myopathies (MAIA) (MAIA)
Primary Purpose
Idiopathic Inflammatory Myopathies
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
description of adult autoimmune myopathies
Sponsored by
About this trial
This is an interventional diagnostic trial for Idiopathic Inflammatory Myopathies
Eligibility Criteria
Inclusion Criteria:
- Clinical suspicion of Adult Inflammatory Myopathy
- Social security affiliation
Exclusion Criteria:
- Pregnant and lactating women
- Patients unable to consent
- Patients refusing to participate in the research.
- Patients under legal protection
Sites / Locations
- CHU de BRESTRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Adult Autoimmune Myopathies
Arm Description
It is a description Autoimmune Myopathie cohort
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04792931
Brief Title
Adult Autoimmune Myopathies (MAIA)
Acronym
MAIA
Official Title
Adult Autoimmune Myopathies (MAIA): Clinical and Immunological Characterization, Constitution of a Patient Library
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
May 20, 2030 (Anticipated)
Study Completion Date
May 20, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 specimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Inflammatory Myopathies
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
diagnosis and follow up of adult autoimmune myopathies
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adult Autoimmune Myopathies
Arm Type
Other
Arm Description
It is a description Autoimmune Myopathie cohort
Intervention Type
Other
Intervention Name(s)
description of adult autoimmune myopathies
Intervention Description
description of adult autoimmune myopathies
Primary Outcome Measure Information:
Title
Distribution of lymphocytes subpopulations (B, T and TH-17)
Description
Distribution of lymphocytes subpopulations (B, T and TH-17) according to the final diagnosis defined by a panel of experts
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical suspicion of Adult Inflammatory Myopathy
Social security affiliation
Exclusion Criteria:
Pregnant and lactating women
Patients unable to consent
Patients refusing to participate in the research.
Patients under legal protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dewi GUELLEC
Phone
0230337617
Email
dewi.guellec@chu-brest.fr
Facility Information:
Facility Name
CHU de BREST
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dewi GUELLEC
Phone
0230337617
Email
dewi.guellec@chu-brest.fr
12. IPD Sharing Statement
Learn more about this trial
Adult Autoimmune Myopathies (MAIA)
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