Clinical trial NCT02377258: IBD Cancer and Serious Infection in Europe
Official title: IBD Cancer and Serious Infection in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBD
Keywords: Lymphoma
safety
biologic therapies
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 13262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 17600 patients in 17 European countries, enrolled by 800 investigators (22 subjects per investigator)

Brief summary: The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.

We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).

Detailed description: The four main secondary objectives of the I-CARE project are:

* 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)

Eligibility criteria: Inclusion Criteria:

* CD or UC
* 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 sign consent
* Unable to access internet or use smartphone
* Refused to sign consent or to provide personal identification information

Primary outcomes:
measure: assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
timeFrame: 3 years
Secondary outcomes:
measure: Disease modification
timeFrame: 3 Years
measure: ePRO
timeFrame: 3 Years
measure: Benefit-Risk
timeFrame: 3 Years
measure: Cost Efficacy
timeFrame: 3 Years
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: Chu Nancy
Study officials:
affiliation: Head of IBD Unit Inserm U954 Nancy University Hospital FRANCE
name: Laurent Peyrin-Biroulet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.