Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
13262 participants
OBSERVATIONAL
2016-03-04
2022-05-16
Brief Summary
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We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).
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Detailed Description
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* To investigate prospectively the impact of anti-TNF based strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations
* To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD
* To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD
* To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD 5-ASA and Steroids across Europe At least 5000 IBD patients treated with 5-ASA or Steroids and FU for 3 years
* use of 5-ASA and efficacy (persistence, switch, mucosal healing etc.)
* chemoprevention of CRC: first study that will specifically and accurately address this question
* use of budesonide mmx and efficacy (clinical efficacy, mucosal healing and potential for disease modification)
* safety of steroids (infections etc)
STUDY DESIGN:
22 patients per investigator. Each Investigator will recruit and enrol 20 patients with imposed treatment stratification : Group 1: 5 without previous or ongoing exposure to IS or biologics, (5 ASA and Steroids are allowed) Group 2: 5 with on-going anti-TNF monotherapy Group 3: 5 with thiopurines monotherapy Group 4: 5 with on-going combination therapy Group 5: 2 patients on vedolizumab (on vedolizumab alone and 1 on combination therapy) (optionnal) Group 6: 5 patients treated with ustekinumab with or without any concomitant medications. (optional)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed)
Non Interventional
2
with on-going anti-TNF monotherapy
Non Interventional
3
with thiopurines monotherapy
Non Interventional
4
with on-going combination therapy
Non Interventional
5
patients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy)
Non Interventional
6
patients on ustekinumab (alone or on combination therapy)
Non Interventional
Interventions
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Non Interventional
Eligibility Criteria
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Inclusion Criteria
* Capable to complete eDiary on a regular basis, and have access to smartphone or internet
* Accepted to participate and provide personal information (name, phone and email) for contact
* Accepted to be contacted by study coordinators on a regular basis for follow up with missing information
Exclusion Criteria
* Unable to access internet or use smartphone
* Refused to sign consent or to provide personal identification information
18 Years
ALL
No
Sponsors
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Principal Investigators
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Laurent Peyrin-Biroulet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Head of IBD Unit Inserm U954 Nancy University Hospital FRANCE
Locations
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Chu Nancy
Vandœuvre-lès-Nancy, , France
Countries
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References
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Peyrin-Biroulet L, Nazar M, Sheahan A, Geldhof A, Azzabi A, Baert F, Mailhat C, Rousseau H, Rahier JF, Beaugerie L. Long-term safety of ustekinumab in Crohn's disease: Descriptive analysis from an observational post-authorisation safety study using I-CARE cohort data. Dig Liver Dis. 2025 Oct 25:S1590-8658(25)01128-4. doi: 10.1016/j.dld.2025.09.026. Online ahead of print.
Peyrin-Biroulet L, Rahier JF, Kirchgesner J, Abitbol V, Shaji S, Armuzzi A, Karmiris K, Gisbert JP, Bossuyt P, Helwig U, Burisch J, Yanai H, Doherty GA, Magro F, Molnar T, Lowenberg M, Halfvarson J, Zagorowicz E, Rousseau H, Baumann C, Baert F, Beaugerie L; I-CARE Collaborator Group. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2023 Mar;21(3):771-788.e10. doi: 10.1016/j.cgh.2022.09.018. Epub 2022 Sep 22.
Other Identifiers
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GETAID 2015-01
Identifier Type: -
Identifier Source: org_study_id
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