Treat-to-target outcomes in adults with Crohn's disease and ulcerative colitis in routine care
Treat-to-Target and Disease Modification in Inflammatory Bowel Disease: A Worldwide Routine Practice Study
This project sees if using a treat-to-target approach in adults with Crohn's disease or ulcerative colitis over 24 months is linked to better disease outcomes in real-world care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 4 sites (Chongqing, Chongqing Municipality and 3 other locations) |
| Trial ID | NCT07421258 on ClinicalTrials.gov |
What this trial studies
This is a multi-country, observational retrospective chart review with a cross-sectional component that examines adult patients with Crohn's disease or ulcerative colitis who have at least 24 months of medical records. Participants were managed according to routine clinical care and not assigned any experimental treatments. The analysis will describe how treat-to-target (T2T) strategies are implemented in real-world practice and examine associations between T2T use and clinical outcomes overall and separately for CD and UC. Primary and secondary objectives focus on a 24-month observation period using existing medical records.
Who should consider this trial
Good fit: Adults aged 18 or older with a diagnosis of Crohn's disease or ulcerative colitis for at least 24 months who can provide informed consent and have at least 24 months of available medical records are ideal candidates.
Not a fit: Patients under legal protection, those with a history of proctocolectomy, those who received investigational treatments within the past 24 months, pediatric patients, or anyone without sufficient medical records are unlikely to be eligible or to benefit from this analysis.
Why it matters
Potential benefit: If successful, the findings could help clinicians adopt T2T approaches more effectively to improve long-term outcomes and personalize care for patients with IBD.
How similar studies have performed: Randomized and cohort studies (for example trials of tight-control management) have shown benefits of treat-to-target approaches, but real-world implementation and outcomes have varied and remain incompletely described.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chongqing, Chongqing Municipality and 3 other locations
- Chongqing General Hospital /ID# 282777 — Chongqing, Chongqing Municipality, China (Recruiting)
- Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 282775 — Nîmes, Gard, France (Not_yet_recruiting)
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 280265 — Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France (Not_yet_recruiting)
- CHU Amiens-Picardie Site Sud /ID# 280263 — Amiens, Somme, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Colla Cunneen
- Email: colla.cunneen@abbvie.com
- Phone: 708-650-3696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.