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 · tracked via the Priya Life Science France tracker

Sponsor

AbbVie

Phase

Observational

Started

2026-02-09

Last updated

2026-03-27

Condition(s) studied

Crohn's DiseaseUlcerative Colitis

Study summary

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

Sex

ALL

Min age

20 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Percentage of Participants Managed Using Treat-to-Target (T2T) — 12 Weeks
Defined as a participant with a therapeutic modification \[dose escalation, change in therapy\] within 12 weeks following any objective disease monitoring that demonstrated active disease.

Trial sites (4)

Facility	City	Region	Status
Chongqing General Hospital /ID# 282777	Chongqing	Chongqing Municipality	Recruiting
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 282775	Nîmes	Gard	Not Yet Recruiting
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 280265	Vandœuvre-lès-Nancy	Meurthe-et-Moselle	Not Yet Recruiting
CHU Amiens-Picardie Site Sud /ID# 280263	Amiens	Somme	Not Yet Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07421258 on ClinicalTrials.gov ↗ ← All trials in France