Pediatric Inflammatory Bowel DiseaseInspiredNCT02392221
Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).
An observational study of Pediatric Inflammatory Bowel Disease, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages Up to 26 years
- Conditions the study is for
- Pediatric Inflammatory Bowel Disease
- How many people
- 966 participants
- Where
- 2 sitesFrance
- Study dates
- May 2015to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric IBD patients in the area of EPIMAD registry Age of diagnosis < 17 years
Who may be able to join
- Patients in the pediatric cohort EPIMAD registry with a diagnosis of CD or UC or probable between 1988 and 2011.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
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.
Read the 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.
- Conditions
- Pediatric Inflammatory Bowel Disease
- Keywords
- Crohn's disease (CD), Pediatric, Inflammatory Bowel Disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: end of follow up
Secondary outcomes (15)
Disease extension according to Montreal classification
Phenotype of MICI maximum monitoring (Montreal classification), according to the date of diagnosis
Measured: end of follow up
Treatment during the follow up
treatment
Measured: end of follow up
information about occurrence of postoperative complications
Presence, date and type of occurrence of postoperative complications (Dindo classification).
Measured: end of follow up
Weight and size
Weight and size at diagnosis, at the first intestinal resection and at the end of follow up
Measured: end of follow up
Hospitalisations
number, duration, date
Measured: end of follow up
Studies category Socio-Professional
Studies category Socio-Professional (CSP) and occupation
Measured: end of follow up
Age of puberty
Age of puberty
Measured: end of follow up
Death
Death and if so; due date and
Measured: end of follow up
Complications
Serious infectious complications and cancer
Measured: end of follow up
cost-effectiveness evalutation of different management strategies of IBD
cost-effectiveness evalutation of different management strategies of IBD according comparison of groups of patients
Measured: end of follow up
cost-effectiveness evalutation of different management strategies of IBD
cost-effectiveness evalutation of different management strategies of IBD according the period of diagnosis
Measured: end of follow up
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
Measured: end of follow up
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.
Measured: at 5 years
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.
Measured: at 15 years
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.
Measured: at 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 966 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Funding from DGOS (PHRC IR 2013 and PRME)
- Responsible party
- Sponsor
- Investigators
- Mathurin Fumery, Doctor, Study director, CHU Amiens FranceJean-Louis Dupas, professor, Study director, CHU Amiens France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392221
- Sponsor's protocol ID
- PI2013_843_0022
- Acronym
- Inspired
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2015
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Ley D, Leroyer A, Dupont C, Sarter H, Bertrand V, Spyckerelle C, Guillon N, Wils P, Savoye G, Turck D, Gower-Rousseau C, Fumery M; Epimad Group. New Therapeutic Strategies Have Changed the Natural History of Pediatric Crohn's Disease: A Two-Decade Population-Based Study. Clin Gastroenterol Hepatol. 2022 Nov;20(11):2588-2597.e1. doi: 10.1016/j.cgh.2022.01.051. Epub 2022 Feb 4.
PubMed 35131345
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).
- ClinicalTrials.gov ID
- NCT02392221
- Acronym / sponsor ID
- Inspired / PI2013_843_0022
- Conditions
- Pediatric Inflammatory Bowel Disease
- Keywords
- Crohn's disease (CD), Pediatric, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 966 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Funding from DGOS (PHRC IR 2013 and PRME)
- Study start
- May 2015
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric IBD patients in the area of EPIMAD registry Age of diagnosis < 17 years
Key inclusion criteria (1 listed)
- Patients in the pediatric cohort EPIMAD registry with a diagnosis of CD or UC or probable between 1988 and 2011.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
15 secondary outcomes
Disease extension according to Montreal classification
Time frame: end of follow up
Treatment during the follow up
Time frame: end of follow up
information about occurrence of postoperative complications
Time frame: end of follow up
Weight and size
Time frame: end of follow up
Hospitalisations
Time frame: end of follow up
Studies category Socio-Professional
Time frame: end of follow up
Age of puberty
Time frame: end of follow up
Death
Time frame: end of follow up
Complications
Time frame: end of follow up
cost-effectiveness evalutation of different management strategies of IBD
Time frame: end of follow up
cost-effectiveness evalutation of different management strategies of IBD
Time frame: end of follow up
cost-effectiveness evalutation of different management strategies of IBD
Time frame: end of follow up
Variation of cost-effectiveness ratio of IBD treatment strategies
Time frame: at 5 years
Variation of cost-effectiveness ratio of IBD treatment strategies
Time frame: at 15 years
Variation of cost-utility ratio of IBD treatment strategies
Time frame: at 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Results publication: PubMed 35131345Ley D, Leroyer A, Dupont C, Sarter H, Bertrand V, Spyckerelle C, Guillon N, Wils P, Savoye G, Turck D, Gower-Rousseau C, Fumery M; Epimad Group. New Therapeutic Strategies Have Changed the Natural History of Pediatric Crohn's Disease: A Two-Decade Population-Based Study. Clin Gastroenterol Hepatol. 2022 Nov;20(11):2588-2597.e1. doi: 10.1016/j.cgh.2022.01.051. Epub 2022 Feb 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathurin Fumery, Doctor study director
CHU Amiens France
Jean-Louis Dupas, professor study director
CHU Amiens France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Inflammatory Bowel Disease, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of surgical resection in CD and colectomy in pediatric UC (time frame: end of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.