IBD Cancer and Serious Infection in Europe

IBD Clinical Trial

— I-CARE  

Official title:

IBD Cancer and Serious Infection in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377258
• Other study ID #: GETAID 2015-01
• Status: Completed
• Start date: March 4, 2016
• Est. completion date: May 16, 2022

Study information

• Verified date: August 2022
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13262
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• IBD
• Infections

Intervention

Other:
• Non Interventional

Locations

Country	Name	City	State
France	Chu Nancy	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Disease modification	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
Secondary	ePRO	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
Secondary	Benefit-Risk	To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD	3 Years
Secondary	Cost Efficacy	To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD	3 Years