Crohn's DiseaseTATOONCT07421258
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
An observational study of Crohn's Disease and Ulcerative Colitis, run by AbbVie at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- How many people
- 1,638 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 9 Feb 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with a physician-confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) >= 2 years prior to enrolment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
France3 sites
CHU Amiens-Picardie Site Sud /ID# 280263
Amiens, Somme, 80054
Centre Hospitalier Universitaire de Nimes - Hopital Universitaire Caremeau /ID# 282775
Nîmes, Gard, 300000
Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 280265
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511
China1 site
Chongqing General Hospital /ID# 282777
Chongqing, Chongqing Municipality, 400013
Japan1 site
Kitasato University Kitasato Institute Hospital /ID# 282803
Minato-ku, Tokyo, 108-8642
About this study
Official title: 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.
Read more
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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Treat-to-Target
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with Inflammatory Bowel Disease | Participants will be managed and followed according to the standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Managed Using Treat-to-Target (T2T)
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start9 Feb 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,638 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421258
- Sponsor's protocol ID
- H25-909
- Acronym
- TATOO
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treat-to-Target and Disease Modification in Inflammatory Bowel Disease: A Worldwide Routine Practice Study
- ClinicalTrials.gov ID
- NCT07421258
- Acronym / sponsor ID
- TATOO / H25-909
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Treat-to-Target
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,638 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Inflammatory Bowel Disease | – | –Participants will be managed and followed according to the standard practice. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with a physician-confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) >= 2 years prior to enrolment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by AbbVie at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Managed Using Treat-to-Target (T2T) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.