Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).

Pediatric Inflammatory Bowel Disease Clinical Trial

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Official title:

Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392221
• Other study ID #: PI2013_843_0022
• Status: Completed
• Start date: May 2015
• Est. completion date: April 2019

Study information

• Verified date: March 2021
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 966
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Pediatric Inflammatory Bowel Disease

Locations

Country	Name	City	State
France	CHRU Lille	Lille
France	CHU Rouen	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Funding from DGOS (PHRC IR 2013 and PRME)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of surgical resection in CD and colectomy in pediatric UC	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.	end of follow up
Secondary	Disease extension according to Montreal classification	Phenotype of MICI maximum monitoring (Montreal classification), according to the date of diagnosis	end of follow up
Secondary	Treatment during the follow up	treatment	end of follow up
Secondary	information about occurrence of postoperative complications	Presence, date and type of occurrence of postoperative complications (Dindo classification).	end of follow up
Secondary	Weight and size	Weight and size at diagnosis, at the first intestinal resection and at the end of follow up	end of follow up
Secondary	Hospitalisations	number, duration, date	end of follow up
Secondary	Studies category Socio-Professional	Studies category Socio-Professional (CSP) and occupation	end of follow up
Secondary	Age of puberty	Age of puberty	end of follow up
Secondary	Death	Death and if so; due date and	end of follow up
Secondary	Complications	Serious infectious complications and cancer	end of follow up
Secondary	cost-effectiveness evalutation of different management strategies of IBD	cost-effectiveness evalutation of different management strategies of IBD according comparison of groups of patients	end of follow up
Secondary	cost-effectiveness evalutation of different management strategies of IBD	cost-effectiveness evalutation of different management strategies of IBD according the period of diagnosis	end of follow up
Secondary	cost-effectiveness evalutation of different management strategies of IBD	cost-effectiveness evalutation of different management strategies of IBD according Markov model of disease natural history	end of follow up
Secondary	Variation of cost-effectiveness ratio of IBD treatment strategies	Variation of cost-effectiveness ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.	at 5 years
Secondary	Variation of cost-effectiveness ratio of IBD treatment strategies	Variation of cost-effectiveness ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.	at 15 years
Secondary	Variation of cost-utility ratio of IBD treatment strategies	Variation of cost-utility ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.	at 15 years