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

NCT07421258 | Recruiting

• 1 other identifier: H25-909
• Study Type: observational
• Target: 2,000
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

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

Outcome Measures

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.

  12 Weeks

Study Arms (1)

Adults with Inflammatory Bowel Disease

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants able to provide voluntary informed consent prior to any study data collection

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

Chongqing General Hospital /ID# 282777

Chongqing, Chongqing Municipality, 400013, China

RECRUITING

Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 282775

Nîmes, Gard, 30029, France

NOT YET RECRUITING

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 280265

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

NOT YET RECRUITING

CHU Amiens-Picardie Site Sud /ID# 280263

Amiens, Somme, 80054, France

NOT YET RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Colla Cunneen

CONTACT

708-650-3696; colla.cunneen@abbvie.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: February 19, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (3); CN (1)