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

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.

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Key information

Conditions

Crohn's Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chongqing General Hospital /ID# 282777, Chongqing, Chongqing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Percentage of Participants Managed Using Treat-to-Target (T2T)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Colla Cunneen

CONTACT

[email protected]

708-650-3696

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: TATOO

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 19, 2026
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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