NCT03432455

Brief Summary

This is a descriptive, retrospective, multi-center, cross-sectional and observational epidemiological study of incidence and prevalence of juvenile dermatomyositis in Alsace from 2000 to 2015. Alsace is a French region with a low migratory flow

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

February 7, 2018

Last Update Submit

February 7, 2018

Conditions

Juvenile Dermatomyositis

Keywords

Incidenceprevalenceepidemiologyjuvenile dermatomyositisinflammatory myopathy

Outcome Measures

Primary Outcomes (1)

  • Identify incident and prevalent cases of juvenile dermatomyositis according to Bohan and Peter's criteria at january 1st, 2016 via capture/recapture strategy

    The period from from January 1st, 2000 to December 31st, 2015 will be examined

Eligibility Criteria

Age1 Day - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patient who have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975

You may qualify if:

  • Age under 16 years
  • Have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975

You may not qualify if:

  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Dermatologie

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

DermatomyositisMyositis

Condition Hierarchy (Ancestors)

PolymyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Central Study Contacts

Dan LIPSKER, MD, PhD

CONTACT

33.3.88.11.61.79dan.lipsker@chru-strasbourg.fr

Céline RAMSTEIN, MD

CONTACT

33.3.88.11.61.79celine.ramstein@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 14, 2018

Study Start

February 7, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 14, 2018

Record last verified: 2018-02

Locations

FR(1)