Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2008). (Inspired)
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|ClinicalTrials.gov Identifier: NCT02392221|
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : August 3, 2018
|Condition or disease|
|Pediatric Inflammatory Bowel Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||966 participants|
|Official Title:||Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2008).|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
- Cumulative incidence of surgical resection in CD and colectomy in pediatric UC [ Time Frame: end of follow up ]Cumulative incidence of surgical resection in CD and colectomy in pediatric ulcerative colitis, depending on the date of diagnosis and the possibility of using immunosuppressants and / or anti-TNFs.
- Disease extension according to Montreal classification [ Time Frame: end of follow up ]Phenotype of MICI maximum monitoring (Montreal classification), according to the date of diagnosis
- Treatment during the follow up [ Time Frame: end of follow up ]treatment
- information about occurrence of postoperative complications [ Time Frame: end of follow up ]Presence, date and type of occurrence of postoperative complications (Dindo classification).
- Weight and size [ Time Frame: end of follow up ]Weight and size at diagnosis, at the first intestinal resection and at the end of follow up
- Hospitalisations [ Time Frame: end of follow up ]number, duration, date
- Studies category Socio-Professional [ Time Frame: end of follow up ]Studies category Socio-Professional (CSP) and occupation
- Age of puberty [ Time Frame: end of follow up ]Age of puberty
- Death [ Time Frame: end of follow up ]Death and if so; due date and
- Complications [ Time Frame: end of follow up ]Serious infectious complications and cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392221
|Contact: Mathurin Fumery, Doctor||322668214 ext +firstname.lastname@example.org|
|Contact: Jean Louis DUPAS, professor||322668214 ext +email@example.com|
|Lille, France, 59000|
|Contact: Gower Rousseau, Doctor 320445518 ext +33|
|Principal Investigator: Corinne Gower-Rousseau, Doctor|
|Sub-Investigator: Luc Dauchet, Doctor|
|CHU Rouen||Not yet recruiting|
|Rouen, France, 7700|
|Contact: Eric Lerebours, professor 232888101 ext +33|
|Contact: Lerebours , professor 232888101 ext +33|
|Sub-Investigator: guillaume Savoye, professor|
|Study Director:||Mathurin Fumery, Doctor||CHU Amiens France|
|Study Director:||Jean-Louis Dupas, professor||CHU Amiens France|