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CompletedNCT07421258TATOOUpdated Oct 5, 2026

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 in Crohn's Disease and Ulcerative Colitis, sponsored by AbbVie. Completed at 5 sites in 3 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by AbbVie · Observational

Updated Oct 5, 2026Now CompletedFirst site in Japan+3 moreGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1,638
Ages
20 Years and older
Sex
All
01

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.

02

Conditions studied

  • Crohn's Disease
  • Ulcerative Colitis

Keywords

  • Inflammatory Bowel Disease
  • Crohn's Disease
  • Ulcerative Colitis
  • Treat-to-Target
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 1,638 is above the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1,638 participants (actual)

Groups and cohorts

  • Adults with Inflammatory Bowel Disease

    Participants will be managed and followed according to the standard practice.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 Weeks

07

Study locations

5 sites
  • Chongqing General Hospital /ID# 282777
    Chongqing, Chongqing Municipality 400013, China
  • Centre Hospitalier Universitaire de Nimes - Hopital Universitaire Caremeau /ID# 282775
    Nîmes, Gard 300000, France
  • Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 280265
    Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54511, France
  • CHU Amiens-Picardie Site Sud /ID# 280263
    Amiens, Somme 80054, France
  • Kitasato University Kitasato Institute Hospital /ID# 282803
    Minato-ku, Tokyo 108-8642, Japan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 5, 2026
Sites
3 sites added, 2 sites removed — first site in Japan
Show 3 added (2 France, 1 Japan)
  • Centre Hospitalier Universitaire de Nimes - Hopital Universitaire Caremeau /ID# 282775 · Nîmes, France
  • Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 280265 · Vandœuvre-lès-Nancy, France
  • Kitasato University Kitasato Institute Hospital /ID# 282803 · Minato-ku, Japan
Show 2 removed
  • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 282775 · Nîmes, France
  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 280265 · Vandœuvre-lès-Nancy, France
Oct 5, 2026
Enrollment
2000 (estimated)→1638 (actual)
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Recruiting→Completed
    3 sites added, 2 sites removed — first site in Japan
    Show 3 added (2 France, 1 Japan)
    • Centre Hospitalier Universitaire de Nimes - Hopital Universitaire Caremeau /ID# 282775 · Nîmes, France
    • Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 280265 · Vandœuvre-lès-Nancy, France
    • Kitasato University Kitasato Institute Hospital /ID# 282803 · Minato-ku, Japan
    Show 2 removed
    • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 282775 · Nîmes, France
    • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 280265 · Vandœuvre-lès-Nancy, France
    Enrollment 2000 (estimated)→1638 (actual)
    + 3 other changes: verification date, date precision and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07421258
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Feb 19, 2026
Start date
Feb 9, 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026
Last update
Oct 5, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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