The study dedicated to IBD.
An innovative study where the patient is the researcher!
An innovative study where the patient is the researcher!
Key figures
What does the final I-CARE cohort represent in a few figures ?
For the patients
0
patient researcher’s actors of this project
0
patients contacted for the study purposes
0
eDiaries sent to patients
0
eDiaries completed by patients
For the investigators
0
assessable patients
0
patient – years
0%
of compliance in the ePRO completion
0
medical reports collected for the coding
0%
of unresolved queries on Annual SummariesAn Annual summary is a recap of data collected along 12 months of follow-up coming from a patient's ePRO questionnaires. It is dedicated to investigators and serves for the control quality of data collection from patient declaration
31/03/2022 : End of Study for all patients
16/05/2022 : last patient out
17/03/2023 : database freezing
508 Participating Investigators
305 Study Nurses
22 contributors (GETAID and external contributors)
15 participating countries
Total included population
Total number of included patients :
13 262
- France : 3757
- United Kingdom : 2985
- Italy : 1051
- Greece : 961
- Sapin : 1026
- Belgium : 601
- Germany : 560
- Denmark : 420
- Israel : 465
- Ireland : 389
- Portugal : 382
- Hungary : 317
- Netherland : 139
- Sweden : 114
- Poland : 91
Assessable population (= Patients with at least 2 ePro completed)
Repartition of total number of assessable patients per country (10 206 patients)
Repartition of assessable population per treatment (10206 patients)
- Group 1: Patients having never received biological agents or immunosuppressant (all 5-ASA and steroids formulations are permitted) and then (protocol amendment n°7) patients receiving no ongoing immunosuppressant and biologic agent at inclusion in I-CARE study (all previous medication accepted) (all 5-ASA and steroids formulations are permitted)
- Group 2: Patients receiving thiopurines alone
- Group 3: Patients treated with anti-TNF therapy alone without any concomitant immunosuppressant
- Group 4: Patients treated with anti-TNF therapy in combination with thiopurines or methotrexate
- Group 5a: Patients treated with vedolizumab alone (without any concomitant immunosuppressant)
- Group 5b: Patients treated with vedolizumab in combination with thiopurines or methotrexate.
- Group 6: Patients treated with ustekinumab with or without any concomitant medications.
Coding status (Based on data extraction on 15th sept 2022)
*between 04/03/2016 (First Patient included) and 16/05/2022 (Last Patient Out)
Total Number of Events (TNE) TO BE CODED = 3918 (Based on data extraction on 15th sept 2022)
*TBD : Coding status to be determined
Coding done
To code
TBD
Cancer N=194
Dysplasia N=167
Hospitalisation N= 2805
Infection N=675
