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Adult 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
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Inflammatory Myopathies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 8, 2021
Last Updated
May 20, 2022
Sponsor
University Hospital, Brest
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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

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Adult Autoimmune Myopathies (MAIA)

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