IBD Cancer and Serious Infection in Europe (I-CARE)

• ClinicalTrials.gov Identifier: NCT02377258
• Recruitment Status: Completed
• First Posted: March 3, 2015
• Last Update Posted: August 3, 2022
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Information provided by (Responsible Party): Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Tracking Information

• First Submitted Date: February 26, 2015
• First Posted Date: March 3, 2015
• Last Update Posted Date: August 3, 2022
• Actual Study Start Date: March 4, 2016
• Actual Primary Completion Date: May 16, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 26, 2015)

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. [ Time Frame: 3 years ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 26, 2015)

• Disease modification [ Time Frame: 3 Years ]
  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 hospitalisations
• ePRO [ Time Frame: 3 Years ]
  To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD
• Benefit-Risk [ Time Frame: 3 Years ]
  To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD
• Cost Efficacy [ Time Frame: 3 Years ]
  To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: IBD Cancer and Serious Infection in Europe
• Official Title: IBD Cancer and Serious Infection in Europe

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)

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: 17600 patients in 17 European countries, enrolled by 800 investigators (22 subjects per investigator)
• Condition: IBD
• Intervention: Other: Non Interventional

Study Groups/Cohorts

• 1
  without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed)
  Intervention: Other: Non Interventional
• 2
  with on-going anti-TNF monotherapy
  Intervention: Other: Non Interventional
• 3
  with thiopurines monotherapy
  Intervention: Other: Non Interventional
• 4
  with on-going combination therapy
  Intervention: Other: Non Interventional
• 5
  patients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy)
  Intervention: Other: Non Interventional
• 6
  patients on ustekinumab (alone or on combination therapy)
  Intervention: Other: Non Interventional

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 8, 2021): 13262
• Original Estimated Enrollment (submitted: February 26, 2015): 17600
• Actual Study Completion Date: May 16, 2022
• Actual Primary Completion Date: May 16, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02377258
• Other Study ID Numbers: GETAID 2015-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Original Responsible Party: Same as current
• Current Study Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Laurent Peyrin-Biroulet, MD, PhD; Head of IBD Unit Inserm U954 Nancy University Hospital FRANCE

• PRS Account: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Verification Date: August 2022