DermatomyositisMIDENCT03293615
Exercise Capacity of Patients with Dermatomyosis
A study testing exploration in people with Dermatomyositis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- exploration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2019to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- - 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, ...),
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- Subject under safeguard of justice,
- Subject under tutelage or under curators,
- Pregnancy (positive pregnancy test)
- Breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Capacity of Patients with Dermatomyosisthe Role of Muscle Mitochondria and Reactive Oxygen Species
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.
- Conditions
- Dermatomyositis
- Being tested
- exploration
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
explorationOther
Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.
| Study group | Role | What they receive |
|---|---|---|
| Dermatomyositis (DM) | Experimental | Patients with dermatomyositis according to ENMC criteria Receives: Other: exploration |
| Non-dermatomyositis inflammatory myopathies | Active comparator | Patients with other inflammatory myopathy than dermatomyositis according to ENMC criteria Receives: Other: exploration |
| No myopathy | No intervention | Patients without myopathy on muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start28 Nov 2019
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Why it stopped: problèmes de recrutement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Meyer, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293615
- Sponsor's protocol ID
- 6431
- Acronym
- MIDE
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capacity of Patients with Dermatomyosisthe Role of Muscle Mitochondria and Reactive Oxygen Species
- ClinicalTrials.gov ID
- NCT03293615
- Acronym / sponsor ID
- MIDE / 6431
- Conditions
- Dermatomyositis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: problèmes de recrutement
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 26 Sep 2017 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dermatomyositis (DM) | Experimental | Other: explorationPatients with dermatomyositis according to ENMC criteria |
| Non-dermatomyositis inflammatory myopathies | Active comparator | Other: explorationPatients with other inflammatory myopathy than dermatomyositis according to ENMC criteria |
| No myopathy | No intervention | –Patients without myopathy on muscle biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- - 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,
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 |
|---|---|---|
| explorationDifference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease. | Other | Dermatomyositis (DM), Non-dermatomyositis inflammatory myopathies |
Primary outcome
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.
Time frame: Baseline
This difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy
Results and safety
The study was stopped early (reason given: problèmes de recrutement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Dermatomyositis
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A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
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Natural History of Inflammatory Muscle Diseases
Inflammation In Skeletal Muscle
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A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
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RecruitingPhase 2
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
Dermatomyositis
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. This study is not recruiting at the moment.
Alain Meyer principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exploration in people with Dermatomyositis, run by University Hospital, Strasbourg, France 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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?
The study was stopped early (reason given: problèmes de recrutement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline). 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 19 Sep 2024.