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 (TATOO)

March 26, 2026 updated by: AbbVie

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400013
        • Recruiting
        • Chongqing General Hospital /ID# 282777
  • France
    • Gard
      • Nîmes, Gard, France, 30029
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 282775
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
        • Not yet recruiting
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 280265
    • Somme
      • Amiens, Somme, France, 80054
        • Not yet recruiting
        • CHU Amiens-Picardie Site Sud /ID# 280263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants with a physician-confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) >= 2 years prior to enrolment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adults with Inflammatory Bowel Disease
Participants will be managed and followed according to the standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H25-909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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