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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377258
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Study Description
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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).


Condition or disease Intervention/treatment
IBD Other: Non Interventional

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 Design
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Study Type : Observational
Actual Enrollment : 13262 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: IBD Cancer and Serious Infection in Europe
Actual Study Start Date : March 4, 2016
Actual Primary Completion Date : May 16, 2022
Actual Study Completion Date : May 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
17600 patients in 17 European countries, enrolled by 800 investigators (22 subjects per investigator)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377258


Locations
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France
Chu Nancy
Vandoeuvre Les Nancy, France, 54500
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Investigators
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Principal Investigator: Laurent Peyrin-Biroulet, MD, PhD Head of IBD Unit Inserm U954 Nancy University Hospital FRANCE
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT02377258    
Other Study ID Numbers: GETAID 2015-01
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
Lymphoma
safety
biologic therapies
Additional relevant MeSH terms:
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Infections