Juvenile DermatomyositisNCT03433638
Juvenile Dermatomyositis
An observational study of Juvenile Dermatomyositis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This is a retrospective descriptive cross-sectional and observational multicenter clinical and progressive study of juvenile dermatomyositis. The aim is to determine the clinical, paraclinical, and evolutive characteristics and therapeutic modalities from a series of juvenile dermatomyositis identified in Alsace… Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Juvenile Dermatomyositis
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2018to Jan 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 1 day to 16 years
- All sexes
- Child
Study population: Patient who have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975
Who may be able to join
- Age under 16 years
- Have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Dermatologie
Strasbourg, 67091
Dan LIPSKER, MD, PhD, 33.3.88.11.61.79, dan.lipsker@chru-strasbourg.fr
Céline Ramstein, MD, 33.3.88.11.61.79, celine.ramstein@chru-strasbourg.fr
About this study
Official title: Retrospective Descriptive Study of Juvenile Dermatomyositis in Alsace
This is a retrospective descriptive cross-sectional and observational multicenter clinical and progressive study of juvenile dermatomyositis. The aim is to determine the clinical, paraclinical, and evolutive characteristics and therapeutic modalities from a series of juvenile dermatomyositis identified in Alsace between 2000 to 2015.
- Conditions
- Juvenile Dermatomyositis
- Keywords
- Juvenile dermatomyositis, Inflammatory myopathy, Clinical features, Treatment
- Medical subject headings
- Dermatomyositis, Myositis
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of clinical characteristics of juvenile dermatomyositis
Measured: The period from from January 1st, 2000 to December 31st, 2015 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start8 Feb 2018
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile DermatomyositisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433638
- Sponsor's protocol ID
- 6785
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Descriptive Study of Juvenile Dermatomyositis in Alsace
- ClinicalTrials.gov ID
- NCT03433638
- Acronym / sponsor ID
- 6785
- Conditions
- Juvenile Dermatomyositis
- Keywords
- Juvenile dermatomyositis, Inflammatory myopathy, Clinical features, Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 14 Feb 2018 (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.
This is a retrospective descriptive cross-sectional and observational multicenter clinical and progressive study of juvenile dermatomyositis. The aim is to determine the clinical, paraclinical, and evolutive characteristics and therapeutic modalities from a series of juvenile dermatomyositis identified in Alsace between 2000 to 2015.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Patient who have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975
Key inclusion criteria (2 listed)
- Age under 16 years
- Have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975
Key exclusion criteria (1 listed)
- Refusal to participate in the study
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
Study of clinical characteristics of juvenile dermatomyositis
Time frame: The period from from January 1st, 2000 to December 31st, 2015 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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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.
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 Juvenile 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 2 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: status not confirmed, as of the sponsor's last update on 27 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan LIPSKER, MD, PhD (33.3.88.11.61.79, dan.lipsker@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of clinical characteristics of juvenile dermatomyositis (time frame: The period from from January 1st, 2000 to December 31st, 2015 will be examined). 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 27 Feb 2018.