Ustekinumab Real World Evidence Study
Completed
Conditions studied: Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT07748338
- Run by
- University Hospital Southampton NHS Foundation Trust
- People needed
- 601
- Starts
- 2019-10-30
- Expected to finish
- 2025-03-20
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Hospitals Bristol NHS Foundation Trust — Bristol, Bristol, United Kingdom
- University Hospitals Dorset NHS Foundation Trust — Bournemouth, Dorset, United Kingdom
- Dorset County Hospital NHS Foundation Trust — Dorchester, Dorset, United Kingdom
- University Hospitals Sussex — Brighton, East Sussex, United Kingdom
- Kingston Hospital NHS Foundation Trust — Kingston, Greater London, United Kingdom
- Barts Health NHS Trust — London, Greater London, United Kingdom
- Guy's and St Thomas' NHS Foundation Trust — London, Greater London, United Kingdom
- Lewisham and Greenwich NHS Trust — London, Greater London, United Kingdom
- Chelsea and Westminster Hospital NHS Foundation Trust — London, Greater London, United Kingdom
- St George's Hospital — London, Greater London, United Kingdom
- Pennine Acute Hospitals NHS Trust — Bury, Greater Manchester, United Kingdom
- Salford Royal NHS Foundation Trust — Salford, Greater Manchester, United Kingdom
- University Hospital Southampton NHS Foundation Trust — Southampton, Hampshire, United Kingdom
- Hampshire Hospitals NHS Foundation Trust — Winchester, Hampshire, United Kingdom
- St Mark's Hospital — Harrow, Middlesex, United Kingdom
- Royal United Hospitals Bath NHS Foundation Trust — Bath, Somerset, United Kingdom
- University Hospital of Wales, Cardiff — Cardiff, South Glamorgan, United Kingdom
- Barnsley Hospital NHS Foundation Trust — Barnsley, South Yorkshire, United Kingdom
- Newcastle Hospitals NHS Foundation Trust — Newcastle, Tyne and Wear, United Kingdom
- Swansea Bay University Health Board — Swansea, West Glamorgan, United Kingdom
- Bradford Teaching Hospitals NHS Foundation Trust — Bradford, West Yorkshire, United Kingdom
- Salisbury NHS Foundation Trust — Salisbury, Wiltshire, United Kingdom
Full record on ClinicalTrials.gov
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