RecruitingRecruiting
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
NCT07421258 · AbbVie
In plain English
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Official title
Treat-to-Target and Disease Modification in Inflammatory Bowel Disease: A Worldwide Routine Practice Study
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 2000 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-02-09
Estimated completion: 2026-09
Last updated: 2026-03-27
Primary outcomes
- • Percentage of Participants Managed Using Treat-to-Target (T2T) (12 Weeks)
Sponsor
AbbVie · industry
Contacts & investigators
ContactColla Cunneen · contact · colla.cunneen@abbvie.com · 708-650-3696
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (4)
Chongqing General Hospital /ID# 282777Recruiting
Chongqing, Chongqing Municipality, China
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 282775Not Yet Recruiting
Nîmes, Gard, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 280265Not Yet Recruiting
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU Amiens-Picardie Site Sud /ID# 280263Not Yet Recruiting
Amiens, Somme, France