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Exercise Capacity of Patients With Dermatomyosis (MIDE)

Primary Purpose

Dermatomyositis

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

exploration

About this trial

This is an interventional prevention trial for Dermatomyositis

Eligibility Criteria

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

Inclusion Criteria:

Woman or man> 18 years,
Signature of informed consent,
Muscle biopsy for suspicion of recent inflammatory myopathy (<6 months) or for exclusion of neuromuscular pathology.

Prospectively, following the results of the muscle biopsy, the subjects will divided into three groups meeting the following criteria:

"DM" group: DM according to the ENMC criteria;
"other inflammatory myopathy" group: polymyositis, autoimmune necrotizing myopathy, non-specific myositis or inclusion myositis according to the ENMC criteria;
Group "no neuromuscular pathology": i) myalgia and / or intolerance to exercise and ii) normal neuromuscular examination, iii) no increase in blood creatine kinase level, iv) absence of electromyographic abnormality, v) histological Muscle mass.

Exclusion Criteria:

- Taking an immunomodulatory treatment within 6 months before inclusion,
Paraneoplastic form of the disease,
Presence of associated interstitial pneumonitis,
Neuromuscular pathology different from inflammatory myopathy,
Unbalanced cardiovascular disease,
Impossibility of giving the subject informed information (subject in an emergency situation, difficulty in understanding the subject, ...),
Subject under safeguard of justice,
Subject under tutelage or under curators,
Pregnancy (positive pregnancy test)
Breastfeeding.

Sites / Locations

MeyerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Dermatomyositis (DM)

Non-dermatomyositis inflammatory myopathies

No myopathy

Arm Description

Patients with dermatomyositis according to ENMC criteria

Patients with other inflammatory myopathy than dermatomyositis according to ENMC criteria

Patients without myopathy on muscle biopsy

Outcomes

Primary Outcome Measures

Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.

This difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy

Secondary Outcome Measures

Full Information

NCT ID

NCT03293615

First Posted

September 15, 2017

Last Updated

August 18, 2023

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT03293615

Brief Title

Exercise Capacity of Patients With Dermatomyosis

Acronym

MIDE

Official Title

Exercise Capacity of Patients With Dermatomyosisthe Role of Muscle Mitochondria and Reactive Oxygen Species

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 28, 2019 (Actual)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which are associated with poor health status and increased mortality. The origin of this muscle impairment remains unknown. The investigators hypothesize that mitochondria functioning is impaired in DM muscle and links with exercise capacities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatomyositis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dermatomyositis (DM)

Arm Type

Experimental

Arm Description

Patients with dermatomyositis according to ENMC criteria

Arm Title

Non-dermatomyositis inflammatory myopathies

Arm Type

Active Comparator

Arm Description

Patients with other inflammatory myopathy than dermatomyositis according to ENMC criteria

Arm Title

No myopathy

Arm Type

No Intervention

Arm Description

Patients without myopathy on muscle biopsy

Intervention Type

Other

Intervention Name(s)

exploration

Intervention Description

Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.

Primary Outcome Measure Information:

Title

Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.

Description

This difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Woman or man> 18 years, Signature of informed consent, Muscle biopsy for suspicion of recent inflammatory myopathy (<6 months) or for exclusion of neuromuscular pathology. Prospectively, following the results of the muscle biopsy, the subjects will divided into three groups meeting the following criteria: "DM" group: DM according to the ENMC criteria; "other inflammatory myopathy" group: polymyositis, autoimmune necrotizing myopathy, non-specific myositis or inclusion myositis according to the ENMC criteria; Group "no neuromuscular pathology": i) myalgia and / or intolerance to exercise and ii) normal neuromuscular examination, iii) no increase in blood creatine kinase level, iv) absence of electromyographic abnormality, v) histological Muscle mass. Exclusion Criteria: - Taking an immunomodulatory treatment within 6 months before inclusion, Paraneoplastic form of the disease, Presence of associated interstitial pneumonitis, Neuromuscular pathology different from inflammatory myopathy, Unbalanced cardiovascular disease, Impossibility of giving the subject informed information (subject in an emergency situation, difficulty in understanding the subject, ...), Subject under safeguard of justice, Subject under tutelage or under curators, Pregnancy (positive pregnancy test) Breastfeeding.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alain Meyer, MD

Phone

00333 6 76 95 31 67

alain.meyer1@chru-strasbourg.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alain Meyer

Organizational Affiliation

Les Hôpitaux Universitaires de Strasbourg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Meyer

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Exercise Capacity of Patients With Dermatomyosis

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