Ibd CAncer and seRious infections in Europe

• Conditions: K50.0; K50.1; K51; K52.3; Crohn disease of small intestine; Crohn disease of large intestine; Ulcerative colitis; Indeterminate colitis

• Registration Number: DRKS00009799
• Lead Sponsor: Hoptial Lariboisière- Service de Gastroenterologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-12
• Study Completion: 2022-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 13262

Inclusion Criteria

Patient with an established diagnosis of Crohn´s disease, ulcerative colits or IBD, unclassified made at least 3 months earlier based on usal radiological, endoscopic or histological criteria.
Patient 18 an older accepting to sign the informed participating consent form, stating that he accepts to provide personal details to complete the electronic studydocumentation as required and to be contacted by a Study Coordinator and his gastroenterologist for the purpose of the study during the entire study period if required.

Exclusion Criteria

Patient unable to sign the informed consent form.
Patient with no regular access to internet.
Treatment at entry in the study with an immunomodulator different from thiopurines and methotrexate.
At the time of inclusion in the study, therapy was not assigned to any of the groups mentioned.
Patient previously enrolled in a randomized clinical trial.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of I-CARE study is to assess prospectively the presence and the extent of safety concerns (cancers (especially lymphoma) and serious infections risks) for anti-TNF or other biologicals 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 seroius infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic). <br>Study duraction 4 years: 1 year inclusion period and 3 years follow-up period

Secondary Outcome Measures

Name	Time	Method
To investigate prospectively the impact of anti-TNF based strategies or other biologicals on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as muscosal healing and disease complications such as bowel damage, surgeries and hospitalizations.<br><br>To assess the evolation of patient-reported outcomes (PROs) on a yearly basis and the impact of anti-TNF agents or other biologicals on PROs in IBD.<br>1 year inclusion period and 3 years follow-up period.<br><br>To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF or other biologicals therapy for IBD.<br><br>To assess the healthcare costs and cost-efficacy of current therapeutic straegies in IBD.<br><br>Study duraction 4 years: 1 year inclusion period and 3 years follow-up period