Clinical trial NCT02392221: Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).
Official title: Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Inflammatory Bowel Disease
Keywords: Crohn's disease (CD)
Pediatric
Inflammatory Bowel Disease
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Funding from DGOS (PHRC IR 2013 and PRME)
First posted: 2015-03-18
Enrollment: 966
Sex: ALL
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric IBD patients in the area of EPIMAD registry Age of diagnosis \< 17 years

Brief summary: Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract.

Detailed description: Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract. These are diseases of multifactorial origin in which environmental and genetic factors are predominant.The EPIMAD registry, the world's largest epidemiological register for IBD, identifying all incident cases in the four departments of the North West of France showed between 1988 and 2007, an increase in the annual incidence of MC 71 % (6.5 / 105 (1988-1990) 11.1 / 105 (2006-2007) p \<0.0001) in the age group 10-19 years. At the same time, the annual incidence of UC decreased 4.3 / 3.5 105 inhabitants / 105 inhabitants (20%), with phenotypic presentation remained stable. The increase in the incidence of CD will contribute to increase its weight in the health system, particularly in the pediatric CD frequently associated with an aggressive phenotype causing specific complications such as malnutrition, pubertal delay or thrive. These complications have a important impact on the quality of life with a long-term risk of functional disability. They may be associated with increased mortality. Immunosuppressants (azathioprine, methotrexate) have been used in pediatric forms only from the 90s and anti-TNF antibodies (infliximab and adalimumab), until the 2000s. These new therapeutic classes have profoundly changed the management of pediatric IBD. Although there is little data on the impact of these new treatments, early introduction of immunosuppressive and anti-TNFs seems to influence the natural history of IBD diagnosed in pediatric age. Anti-TNFs appear to be associated with more frequent and deeper remission. With the advent of these new treatment, new therapeutic targets such as endoscopic mucosal healing and more recently the deep remission combining clinical remission, biological and endoscopic, appears. However there is no data in the general population assessing the impact of new treatments and new therapeutic strategies in the pediatric population. Potential risks associated with the increasing use and early use of biological treatments in this particular population remain to be determined in the general population.

The main hypothesis of this study is that changes in therapeutic strategies in IBD diagnosed before 17 yeras old could influence the cumulative incidence of surgical resection and complications specific to this population as failure to thrive and delayed puberty, insertion socio-professional, the extension of the disease, hospitalization rates, and the rate of cancer.

Eligibility criteria: Inclusion Criteria:

Patients in the pediatric cohort EPIMAD registry with a diagnosis of CD or UC or probable between 1988 and 2011.

Exclusion Criteria:

* None

Primary outcomes:
measure: Cumulative incidence of surgical resection in CD and colectomy in pediatric UC
timeFrame: end of follow up
Secondary outcomes:
measure: Disease extension according to Montreal classification
timeFrame: end of follow up
measure: Treatment during the follow up
timeFrame: end of follow up
measure: information about occurrence of postoperative complications
timeFrame: end of follow up
measure: Weight and size
timeFrame: end of follow up
measure: Hospitalisations
timeFrame: end of follow up
measure: Studies category Socio-Professional
timeFrame: end of follow up
measure: Age of puberty
timeFrame: end of follow up
measure: Death
timeFrame: end of follow up
measure: Complications
timeFrame: end of follow up
measure: cost-effectiveness evalutation of different management strategies of IBD
timeFrame: end of follow up
measure: cost-effectiveness evalutation of different management strategies of IBD
timeFrame: end of follow up
measure: cost-effectiveness evalutation of different management strategies of IBD
timeFrame: end of follow up
measure: Variation of cost-effectiveness ratio of IBD treatment strategies
timeFrame: at 5 years
measure: Variation of cost-effectiveness ratio of IBD treatment strategies
timeFrame: at 15 years
measure: Variation of cost-utility ratio of IBD treatment strategies
timeFrame: at 15 years
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU Lille
city: Rouen
country: France
facility: CHU Rouen
Study officials:
affiliation: CHU Amiens France
name: Mathurin Fumery, Doctor
role: STUDY_DIRECTOR
affiliation: CHU Amiens France
name: Jean-Louis Dupas, professor
role: STUDY_DIRECTOR
References: