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 or other biologic alone or in combination with thiopurines among IBD patients. Safety profile of all steroids formulation will also be analysed. We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).
The four main secondary objectives of the I-CARE project are:
This is a European prospective longitudinal observational multicenter cohort study. A total of 15 participating countries: Belgium, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Portugal, Spain, Sweden, and United Kingdom. In France, the Investigators have been selected by the National Coordinators (Vered Abitbol and Stéphane Nahon) from the members of EPIMAD, ANGH and CREGG, as well as the GETAID.
Study duration: 6 years
Calculation of sample size was made based on the primary objective of ICARE. We estimated that a minimum of 47,000 patient-years are needed for the study to have a statistical power of 80% to detect a lymphoma hazard ratio of at least 3.5 in the groups of patients receiving thiopurines, either alone or in combination with anti-TNF, vedolizumab or ustekinumab, relative to patients not receiving thiopurines (i.e. receiving anti-TNF alone or no IS). The final patient population will be up to 17,600 and the follow-up duration for each patient will be 3 years. If necessary, we will consider extending the inclusion duration and/or the follow up of patient over 3 years to reach our objective of 47,000 patients-years. A total of up to 800 investigators working in reference centers in IBD will be recruited via ECCO and National Coordinators.
Investigators will be all European gastroenterologists from the participating countries voluntary for participating in the study on an unpaid basis, and accepting to provide phone number and e-mail address for the purpose of the study.
Each investigator will include a total of 27 inpatients or outpatients that he personally manages for IBD, matching the inclusion criteria and stratified according to the exposure to immunosuppressive therapy at inclusion:
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.
The executive committee is in charge of the initial construction of the scientific content and logistic architecture of the project, organisation and project oversight.
President of Scientific Committee
Director of Infections Committee
ECCO / BIRD
The scientific committee (at least 2 meetings per year) will decide and control all aspects of the scientific content and production of initial and secondary nested projects, and the relationship with scientific organizations, Drug Agencies, and Patients Associations. The scientific committee consists of:
The clinical team (I-CARE team) is in charge of the trial conduct and interacts with all project stakeholders: patients, investigators, national coordinators, Executive Committee, safety department and the study vendors.
The clinical operation team consists of :
The pharmacovigilance is in charge of the study safety and the reporting to the local regulatory authorities. The safety team consists of :