PolymyositisEPIDEMYOSITISNCT02880527
Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy
An observational study of Polymyositis and Dermatomyositis, run by University Hospital, Rouen at 1 site in France.
Trial summary
Polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an important factor of morbidity and mortality in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polymyositis, Dermatomyositis
- What is being tested?
- Patients with polymyositis / dermatomyositis
- How many people
- 187 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to May 2016
- Phase
- Observational
- 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
Study population: Patients living in the Normandy with polymyositis / dermatomyositis
Who may be able to join
- patients with polymyositis / dermatomyositis, meeting the diagnostic criteria for ENMC;
- patient living Normandy ;
- patient has been informed and has given its verbal agreement ;
Who cannot join
- patients with myositis diagnosed before inclusion (including pathophysiology, clinical phenotype and therapeutic care are different from polymyositis / dermatomyositis)
Trial locations and contacts
1 site in 1 country.
About this study
Polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an important factor of morbidity and mortality in these patients. At present, studies that evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis has been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria of Bohan and Peter). However, previous works are old and retrospective; above all, they have almost always been performed (90% of cases) from cases reported to the hospital, leading to selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis in the general population.
Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based on the population of Normandy.
- Conditions
- Polymyositis, Dermatomyositis
- Being tested
- Patients with polymyositis / dermatomyositis
- Medical subject headings
- Polymyositis, Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with polymyositis / dermatomyositisOther
recruitment of patients with polymyositis / dermatomyositis using :
- medical specialists , hospital and liberals who support patients with polymyositis / dermatomyositis ( internists , dermatologists, neurologists, pulmonologists , rheumatologists ) ;
- general practitioners
- the PMSI data for public and private hospitals ; 4 ) data boxes regional health insurance (primary health insurance fund , MSA Normandy , Social Scheme for Self )
- Norman patients, members of an association of patients with polymyositis / dermatomyositis : the French Muscular Dystrophy Association
| Study group | Role | What they receive |
|---|---|---|
| patients with polymyositis / dermatomyositis | recruitment of patients with polymyositis / dermatomyositis will be used:
1. medical specialists , hospital and liberals who support patients with polymyositis / dermatomyositis ( internists , dermatologists, neurologists, pulmonologists , rheumatologists ) ;
2. general practitioners
3. the PMSI data for public and private hospitals ; 4 ) data boxes regional health insurance (primary health insurance fund , MSA Normandy , Social Scheme for Self )
5) Norman patients, members of an association of patients with polymyositis / dermatomyositis : the French Muscular Dystrophy Association Receives: Other: Patients with polymyositis / dermatomyositis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed diagnosis of polymyositis / dermatomyositis
recruitment of patients with polymyositis / dermatomyositis
Measured: approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolymyositisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle MARIE, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880527
- Sponsor's protocol ID
- 2013/007/HP
- Acronym
- EPIDEMYOSITIS
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy
- ClinicalTrials.gov ID
- NCT02880527
- Acronym / sponsor ID
- EPIDEMYOSITIS / 2013/007/HP
- Conditions
- Polymyositis, Dermatomyositis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
Polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an important factor of morbidity and mortality in these patients. At present, studies that evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis has been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria of Bohan and Peter). However, previous works are old and retrospective; above all, they have almost always been performed (90% of cases) from cases reported to the hospital, leading to selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis in the general population.
Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based on the population of Normandy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with polymyositis / dermatomyositis | – | Other: Patients with polymyositis / dermatomyositisrecruitment of patients with polymyositis / dermatomyositis will be used: 1. medical specialists , hospital and liberals who support patients with polymyositis / dermatomyositis ( internists , dermatologists, neurologists, pulmonologists , rheumatologists ) ; 2. general practitioners 3. the PMSI data for public and private hospitals ; 4 ) data boxes regional health insurance (primary health insurance fund , MSA Normandy , Social Scheme for Self ) 5) Norman patients, members of an association of patients with polymyositis / dermatomyositis : the French Muscular Dystrophy Association |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living in the Normandy with polymyositis / dermatomyositis
Key inclusion criteria (3 listed)
- patients with polymyositis / dermatomyositis, meeting the diagnostic criteria for ENMC;
- patient living Normandy ;
- patient has been informed and has given its verbal agreement ;
Key exclusion criteria (1 listed)
- patients with myositis diagnosed before inclusion (including pathophysiology, clinical phenotype and therapeutic care are different from polymyositis / dermatomyositis)
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 |
|---|---|---|
| Patients with polymyositis / dermatomyositisrecruitment of patients with polymyositis / dermatomyositis using : 1. medical specialists , hospital and liberals who support patients with polymyositis / dermatomyositis ( internists , dermatologists, neurologists, pulmonologists , rheumatologists ) ; 2. general practitioners 3. the PMSI data for public and private hospitals ; 4 ) data boxes regional health insurance (primary health insurance fund , MSA Normandy , Social Scheme for Self ) 5) Norman patients, members of an association of patients with polymyositis / dermatomyositis : the French Muscular Dystrophy Association | Other | patients with polymyositis / dermatomyositis |
Primary outcome
Confirmed diagnosis of polymyositis / dermatomyositis
Time frame: approximately 1 month
recruitment of patients with polymyositis / dermatomyositis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
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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.
Isabelle MARIE, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymyositis and Dermatomyositis, run by University Hospital, Rouen 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 26 Aug 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Confirmed diagnosis of polymyositis / dermatomyositis (time frame: approximately 1 month). 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 26 Aug 2016.