PolymyositisPREMIANCT02881450
Epidemiological Study of Inflammatory Myopathies in a French Region
An observational study of Polymyositis, run by University Hospital, Strasbourg, France.
Trial summary
Knowledge of the descriptive epidemiology of MIs is very limited. The main objective of this study is to determine the prevalence of inflammatory myopathies in Alsace at the 1st January 2012 with "capture-recapture" design using several independent sources of case identification. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polymyositis
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Resident of Alsace region located in North-east France
Who may be able to join
- All patient reported suffering from inflammatory myopathy
- Meeting the Hoogendijk, Troyanov and Griggs classification criteria
- Alive at 1st January 2012- Domiciled in Alsace (Bas-Rhin or Haut-Rhin counties of France)
Who cannot join
- All patient reported with a different or incomplete diagnosis of inflammatory myopathy (not meeting the Hoogendijk, Troyanov and Griggs criteria)
- All patient dead and/or non-domiciled in Alsace at 1st January 2012
About this study
Official title: Prevalence of Inflammatory Myopathies in Alsace
Knowledge of the descriptive epidemiology of MIs is very limited. The main objective of this study is to determine the prevalence of inflammatory myopathies in Alsace at the 1st January 2012 with "capture-recapture" design using several independent sources of case identification.
Read the detailed description
Inflammatory myopathies (MIs) are a group of muscle diseases with a significant heterogeneity, clinical, immunological and prognosis.
The old classifications, still currently used, highlight this heterogeneity. Therefore Troyanov and coll. and Hoogendijk and coll. have each recently proposed a classification based on clinical and serological - and immuno- histological examination.
The pathogenesis and prognosis of MIs is very different depending on the entity in question.
Knowledge of the descriptive epidemiology of MIs is very limited. In fact no epidemiological work using criteria consensual classification is actually started.
We propose an epidemiological study of MIs. The main objective of the study is to determine the prevalence of MIs in Alsace at 1stJanuary 2012 by means of a "capture- recapture" study using several independent sources of case identification. The secondary objectives of the study are:
- estimating the geographical distribution of the disease in the Alsace region and / or Auvergne
- demographic description of patients : age, sex, residence , occupation
- description of the disease: patient age at diagnosis, disease classification , main clinical manifestations and complications
- Identification of paraneoplastic forms will be for the Alsace region by crossing with Alsatian cancer registries. These records will be interviewed to identify cases of MIs associated with cancers.
- Conditions
- Polymyositis
- Medical subject headings
- Polymyositis
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the prevalence of idiopathic inflammatory myopathies in Alsace.
Measured: Prevalence of idiopathic inflammatory myopathies in Alsace at 1st January 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJan 2012
- Primary completionAug 2019
- Study completionAug 2019
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, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean SIBILIA, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881450
- Sponsor's protocol ID
- 4963
- Acronym
- PREMIA
- Status last verified
- Aug 2019
- First submitted
- 19 Dec 2013
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Inflammatory Myopathies in Alsace
- ClinicalTrials.gov ID
- NCT02881450
- Acronym / sponsor ID
- PREMIA / 4963
- Conditions
- Polymyositis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 29 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.
Knowledge of the descriptive epidemiology of MIs is very limited. The main objective of this study is to determine the prevalence of inflammatory myopathies in Alsace at the 1st January 2012 with "capture-recapture" design using several independent sources of case identification.
Detailed description
Inflammatory myopathies (MIs) are a group of muscle diseases with a significant heterogeneity, clinical, immunological and prognosis.
The old classifications, still currently used, highlight this heterogeneity. Therefore Troyanov and coll. and Hoogendijk and coll. have each recently proposed a classification based on clinical and serological - and immuno- histological examination.
The pathogenesis and prognosis of MIs is very different depending on the entity in question.
Knowledge of the descriptive epidemiology of MIs is very limited. In fact no epidemiological work using criteria consensual classification is actually started.
We propose an epidemiological study of MIs. The main objective of the study is to determine the prevalence of MIs in Alsace at 1stJanuary 2012 by means of a "capture- recapture" study using several independent sources of case identification. The secondary objectives of the study are:
- estimating the geographical distribution of the disease in the Alsace region and / or Auvergne
- demographic description of patients : age, sex, residence , occupation
- description of the disease: patient age at diagnosis, disease classification , main clinical manifestations and complications
- Identification of paraneoplastic forms will be for the Alsace region by crossing with Alsatian cancer registries. These records will be interviewed to identify cases of MIs associated with cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Resident of Alsace region located in North-east France
Key inclusion criteria (3 listed)
- All patient reported suffering from inflammatory myopathy
- Meeting the Hoogendijk, Troyanov and Griggs classification criteria
- Alive at 1st January 2012- Domiciled in Alsace (Bas-Rhin or Haut-Rhin counties of France)
Key exclusion criteria (2 listed)
- All patient reported with a different or incomplete diagnosis of inflammatory myopathy (not meeting the Hoogendijk, Troyanov and Griggs criteria)
- All patient dead and/or non-domiciled in Alsace at 1st January 2012
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate the prevalence of idiopathic inflammatory myopathies in Alsace.
Time frame: Prevalence of idiopathic inflammatory myopathies in Alsace at 1st January 2012
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 20 Aug 2019.
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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.
Jean SIBILIA, MD principal investigator
University Hospital, Strasbourg, France
Questions about this trial
What is this clinical trial studying?
An observational study of Polymyositis, run by University Hospital, Strasbourg, 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 2 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Estimate the prevalence of idiopathic inflammatory myopathies in Alsace. (time frame: Prevalence of idiopathic inflammatory myopathies in Alsace at 1st January 2012). 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 20 Aug 2019.