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Completed

NCT Number: NCT02392221

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

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

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Key information

Age range

Up to 26 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Lille, Lille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Treatment during the follow up

    Time frame: end of follow up

    treatment

  3. information about occurrence of postoperative complications

    Time frame: end of follow up

    Presence, date and type of occurrence of postoperative complications (Dindo classification).

  4. 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

  5. Hospitalisations

    Time frame: end of follow up

    number, duration, date

  6. Studies category Socio-Professional

    Time frame: end of follow up

    Studies category Socio-Professional (CSP) and occupation

  7. Age of puberty

    Time frame: end of follow up

    Age of puberty

  8. Death

    Time frame: end of follow up

    Death and if so; due date and

  9. Complications

    Time frame: end of follow up

    Serious infectious complications and cancer

  10. cost-effectiveness evalutation of different management strategies of IBD

    Time frame: end of follow up

    cost-effectiveness evalutation of different management strategies of IBD according comparison of groups of patients

  11. cost-effectiveness evalutation of different management strategies of IBD

    Time frame: end of follow up

    cost-effectiveness evalutation of different management strategies of IBD according the period of diagnosis

  12. cost-effectiveness evalutation of different management strategies of IBD

    Time frame: end of follow up

    cost-effectiveness evalutation of different management strategies of IBD according Markov model of disease natural history

  13. Variation of cost-effectiveness ratio of IBD treatment strategies

    Time frame: at 5 years

    Variation of cost-effectiveness ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.

  14. Variation of cost-effectiveness ratio of IBD treatment strategies

    Time frame: at 15 years

    Variation of cost-effectiveness ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.

  15. Variation of cost-utility ratio of IBD treatment strategies

    Time frame: at 15 years

    Variation of cost-utility ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Funding from DGOS (PHRC IR 2013 and PRME)

Registry information

Acronym: Inspired

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2015
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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