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

Study acronym: TATOO
StatusCompleted
PhaseNot specified
SponsorAbbVie
Started

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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Final enrollment: 1638 participants (planned 2000)
    • Study sites: 4 to 5
    • Primary and study completion dates changed from estimate of Sep 2026 to Sep 1, 2026
    • Eligibility criteria expanded, about 7 words
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Feb 15, 2026 to Feb 9, 2026
    v2
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07421258
Lead Sponsor AbbVie
Conditions
(from sponsor)
Crohn's Disease, Ulcerative Colitis
Related terms Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Enrollment 1,638 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov