NCT04792931

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
49mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
May 2022May 2030

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2030

Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

8 years

First QC Date

March 8, 2021

Last Update Submit

February 4, 2025

Conditions

Idiopathic Inflammatory Myopathies

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Study Arms (1)

Adult Autoimmune Myopathies

OTHER

It is a description Autoimmune Myopathie cohort

Other: description of adult autoimmune myopathies

Interventions

description of adult autoimmune myopathiesOTHER

description of adult autoimmune myopathies

Adult Autoimmune Myopathies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical suspicion of Adult Inflammatory Myopathy
  • Social security affiliation

You may not qualify if:

  • Pregnant and lactating women
  • Patients unable to consent
  • Patients refusing to participate in the research.
  • Patients under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de BREST

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Myositis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Dewi GUELLEC

CONTACT

0230337617dewi.guellec@chu-brest.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: diagnosis and follow up of adult autoimmune myopathies
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

May 20, 2022

Primary Completion (Estimated)

May 20, 2030

Study Completion (Estimated)

May 20, 2030

Last Updated

February 5, 2025

Record last verified: 2025-02

Locations

FR(1)