IBD Cancer and Serious Infections in Europe




I-CARE is the first observational European prospective cohort study that will provide unique information (safety, efficacy, risk-benefit ratio, and healthcare costs) on the long-term use of recommended therapy in IBD, using a predefined standardized follow-up. These real world data will be used to guide clinicians as well as Healthcare authorities to provide the best care for IBD patients by optimizing available therapies.

Recruitment began in Ireland in May 2017 and so far we have 14 active investigators who have recruited over 100 patients. We aim to recruit approximately 500 patients across 14 sites by the end of the recruitment period.

Study Design

16,000 patients with IBD will be recruited across Europe (with a target of recruiting 500 patients in
Ireland) and they will be followed for three years.


Patients will report outcomes of treatment every month using a customized web based application with yearly physician validation of important events.

Each investigator will include a total of 22 inpatients or outpatients that she/he personally manages for IBD, matching the inclusion criteria and stratified according to the exposure to immunosuppressive therapy at inclusion:

– Group 1: 5 patients who have never received biological agents or immunosuppressant (all 5-ASA and steroids formulations are permitted)
– Group 2: 5 patients receiving thiopurines alone
– Group 3: 5 patients treated with anti-TNF therapy alone without any concomitant immunosuppressant
– Group 4: 5 patients treated with anti-TNF therapy in combination with thiopurines or methotrexate
– Group 5: 2 patients: For investigators following IBD patients treated with vedolizumab, a 5th Group is constituted with enrollment of one patient treated with vedolizumab alone (without any concomitant immunosuppressant) and one patient treated with vedolizumab in combination with thiopurines or methotrexate.

Inclusion criteria:

  • Patient with an established diagnosis of Crohn’s disease, ulcerative colitis or IBD, unclassified made at least 3 months earlier based on usual radiological, endoscopic or histological criteria.
  • Patient 18 and older accepting to sign the informed participating consent form, stating that he accepts to provide personal details (mobile and home phone number, e-mail address), to complete the e-PRO as required and to be contacted by a Study Coordinator and his gastroenterologist for the purpose of the study during the entire study period and during follow up if required.


Exclusion criteria:

  • Patient unable to sign the informed consent form
  • Patient with no regular access to internet
  • Patient refusing to sign the informed consent form
  • Treatment at entry in the study with an immunomodulator different from thiopurines and methotrexate (cyclosporine, tacrolimus, mycophenolate mofetil, etc.)
  • Patient previously enrolled in a Randomized Clinical Trial (If the investigational product received was blinded, and if the treatment is unknown at time of enrollment in I-CARE)


Recruitment to date

As of July 2017 I-CARE has recruited over 5000 patients across 15 countries. Here in Ireland we have recruited 270 patients, 65% of our target.


March 2017 was our best month so far but the aim is to improve on recruitment every month.

If you are an I-CARE investigator who feels they would benefit from some more training resources, or you are a Gastroenterologist who would like to participate in I-CARE as part of our Irish cohort, please contact initiativeibd@gmail.com