NCT07748338Completed
Ustekinumab Real World Evidence Study
UndieS: Ustekinumab Real World Evidence Study
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 601 (actual)
- First submitted
- 25 Jan 2021
- Start date
- 30 Oct 2019
- Primary completion date
- 20 Mar 2025
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Diseases
- Crohn's disease
- NCT number
- NCT07748338
What you commit to
- Study type: Observational
- Participants enrolled: 601
- From 30 Oct 2019 to the primary completion date, 20 Mar 2025
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received ustekinumab previously
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barnsley Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Barnsley | United Kingdom | Unknown status |
| Royal United Hospitals Bath NHS Foundation Trust Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
| University Hospitals Dorset NHS Foundation Trust Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| Bradford Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| University Hospitals Sussex Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| University Hospitals Bristol NHS Foundation Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Pennine Acute Hospitals NHS Trust Coordinator of this site? Confirm its status | Bury | United Kingdom | Unknown status |
| University Hospital of Wales, Cardiff Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Dorset County Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Dorchester | United Kingdom | Unknown status |
| St Mark's Hospital Coordinator of this site? Confirm its status | Harrow | United Kingdom | Unknown status |
| Kingston Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Kingston | United Kingdom | Unknown status |
| St. George's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Lewisham and Greenwich NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Chelsea and Westminster Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Newcastle Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Salford Royal NHS Foundation Trust Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Salisbury NHS Foundation Trust Coordinator of this site? Confirm its status | Salisbury | United Kingdom | Unknown status |
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Swansea Bay University Health Board Coordinator of this site? Confirm its status | Swansea | United Kingdom | Unknown status |
| Hampshire Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Winchester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.