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Completed
NCT07748338
Ustekinumab Real World Evidence Study
Conditions: Crohn's Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 601
Sponsor: University Hospital Southampton NHS Foundation Trust
Location: University Hospitals Bristol NHS Foundation Trust Bristol Bristol
Summary
The purpose of this study is to capture the real-world experience of CD patients treated with ustekinumab as part of their clinical care in a variety of care settings from large teaching/research centres to smaller district hospitals.
Eligibility Criteria
Inclusion Criteria:
* Participants being given ustekinumab as part of their routine clinical care
* Any of the following clinical indications:
* CRP of 5mg/L or higher within three months prior to baseline
* Faecal calprotectin of 250mg/L or higher within three months prior to baseline
* Active disease on endoscopy within 6 months prior to baseline
* Switching to ustekinumab because of an AE on another treatment
* Post-operative prophylaxis
* Age 18 or over
* Able to give informed consent
* Able to read English
Exclusion Criteria:
* Patient is, in the opinion of the investigator, not suitable to participate in the study
* Use of ustekinumab outside of UK SmPC
* Currently enrolled in an IMP/interventional study
* Has received ustekinumab previously
Source: ClinicalTrials.gov (NCT07748338). StuddyBuddy aggregates publicly available trial information.