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Completed

NCT Number: NCT02377258

IBD Cancer and Serious Infection in Europe

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).

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Key information

Conditions

IBD Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Nancy

Vandœuvre-lès-Nancy, 54500, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non Interventional

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Cost Efficacy

    Time frame: 3 Years

    To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Registry information

Acronym: I-CARE

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2015
Registry last updated
Aug 3, 2022

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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