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RECRUITINGOBSERVATIONAL

A Retrospective Study to Evaluate Treat-to-Target and Disease Modification in Adult Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting

Treat-to-Target and Disease Modification in Inflammatory Bowel Disease: A Worldwide Routine Practice Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Inflammatory Bowel Disease (IBD), encompassing Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, relapsing, and often disabling condition characterized by inflammation of the gastrointestinal tract. A treat-to-target strategy (T2T) is recommended by international guidelines to optimize long-term outcomes in IBD. The purpose of this study is to describe the real-life implementation of T2T in IBD worldwide and the association between using a T2T strategy and disease outcomes. This is a multi-country, observational, retrospective (non-interventional) study with a cross-sectional component based upon a sample of adult participants with IBD. All objectives will be assessed for IBD and then for CD/UC separately. Primary and secondary objectives will be assessed for the overall population over the 24 months study period. As this is an observational study, enrolled participants will be managed and followed up according to the standard practice. Retrospective chart review over the 24-months from date of inclusion will allow us to collect the variables of interest by using an e-CRF. There will be no additional burden for participants in this trial. Study visits will not be required as this is a retrospective chart review.

Who May Be Eligible (Plain English)

Who May Qualify: - Adult male and female participants (\>= 18 years old) at the inclusion date who present within the usual course of care - Participants able to provide voluntary willing to sign a consent form prior to any study data collection - Participant diagnosed with Crohn's Disease (CD) or Ulcerative Colitis (UC) for at least 24 months at the inclusion date - With \>= 24 months of available medical records from the inclusion date Who Should NOT Join This Trial: - Participants who had received treatment with any investigational drug/device/intervention over the past 24 months prior to the enrolment - Participants under legal protection - History of proctocolectomy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Adult male and female participants (\>= 18 years old) at the inclusion date who present within the usual course of care * Participants able to provide voluntary informed consent prior to any study data collection * Participant diagnosed with Crohn's Disease (CD) or Ulcerative Colitis (UC) for at least 24 months at the inclusion date * With \>= 24 months of available medical records from the inclusion date Exclusion Criteria: * Participants who had received treatment with any investigational drug/device/intervention over the past 24 months prior to the enrolment * Participants under legal protection * History of proctocolectomy

Locations (4)

Chongqing General Hospital /ID# 282777
Chongqing, Chongqing Municipality, China
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 282775
Nîmes, Gard, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 280265
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU Amiens-Picardie Site Sud /ID# 280263
Amiens, Somme, France