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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07421258

Acronym

TATOO

Enrollment

2000

Registered

2026-02-19

Start date

2026-02-09

Completion date

2026-09-01

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

Keywords

Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Treat-to-Target

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China, France

Contacts

CONTACTColla Cunneen

colla.cunneen@abbvie.com708-650-3696

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results