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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status: Completed

Conditions: IBD

Treatments: Other: Non Interventional

Study type: Observational

Funder types: Other

Identifiers

NCT02377258

GETAID 2015-01

Details and patient eligibility

About

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).

Full 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)

Enrollment: 13,262 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

13,262 participants in 6 patient groups

1

Description:

without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed)

Treatment:

Other: Non Interventional

2

Description:

with on-going anti-TNF monotherapy

Treatment:

Other: Non Interventional

3

Description:

with thiopurines monotherapy

Treatment:

Other: Non Interventional

4

Description:

with on-going combination therapy

Treatment:

Other: Non Interventional

5

Description:

patients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy)

Treatment:

Other: Non Interventional

6

Description:

patients on ustekinumab (alone or on combination therapy)

Treatment:

Other: Non Interventional