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 Identifier
H25-909
CT.gov Identifier
NCT07421258
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Crohn's Disease (CD)
  • Ulcerative Colitis (UC)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Chongqing General Hospital /ID# 282777
    Chongqing, Chongqing Municipality, China, 400013
    Status
    Recruiting
    Location
    Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 282775
    Nîmes, Gard, France, 30029
    Status
    Not yet recruiting
    Location
    Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 280265
    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
    Status
    Not yet recruiting
    Location
    CHU Amiens-Picardie Site Sud /ID# 280263
    Amiens, Somme, France, 80054
    Status
    Not yet recruiting