- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02377258
IBD Cancer and Serious Infection in Europe (I-CARE)
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).
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Vandoeuvre Les Nancy, France, 54500
- CHU Nancy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed)
|
|
2
with on-going anti-TNF monotherapy
|
|
3
with thiopurines monotherapy
|
|
4
with on-going combination therapy
|
|
5
patients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy)
|
|
6
patients on ustekinumab (alone or on combination therapy)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 Years
|
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 Years
|
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
|
3 Years
|
Cost Efficacy
Time Frame: 3 Years
|
To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD
|
3 Years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Laurent Peyrin-Biroulet, MD, PhD, Head of IBD Unit Inserm U954 Nancy University Hospital FRANCE
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GETAID 2015-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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