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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
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

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Barnsley Hospital NHS Foundation Trust
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BarnsleyUnited KingdomUnknown status
Royal United Hospitals Bath NHS Foundation Trust
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BathUnited KingdomUnknown status
University Hospitals Dorset NHS Foundation Trust
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BournemouthUnited KingdomUnknown status
Bradford Teaching Hospitals NHS Foundation Trust
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BradfordUnited KingdomUnknown status
University Hospitals Sussex
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BrightonUnited KingdomUnknown status
University Hospitals Bristol NHS Foundation Trust
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BristolUnited KingdomUnknown status
Pennine Acute Hospitals NHS Trust
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BuryUnited KingdomUnknown status
University Hospital of Wales, Cardiff
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CardiffUnited KingdomUnknown status
Dorset County Hospital NHS Foundation Trust
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DorchesterUnited KingdomUnknown status
St Mark's Hospital
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HarrowUnited KingdomUnknown status
Kingston Hospital NHS Foundation Trust
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KingstonUnited KingdomUnknown status
St. George's Hospital
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LondonUnited KingdomUnknown status
Guy's and St Thomas' NHS Foundation Trust
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LondonUnited KingdomUnknown status
Lewisham and Greenwich NHS Trust
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LondonUnited KingdomUnknown status
Chelsea and Westminster Hospital NHS Foundation Trust
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LondonUnited KingdomUnknown status
Barts Health NHS Trust
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LondonUnited KingdomUnknown status
Newcastle Hospitals NHS Foundation Trust
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NewcastleUnited KingdomUnknown status
Salford Royal NHS Foundation Trust
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SalfordUnited KingdomUnknown status
Salisbury NHS Foundation Trust
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SalisburyUnited KingdomUnknown status
University Hospital Southampton NHS Foundation Trust
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SouthamptonUnited KingdomUnknown status
Swansea Bay University Health Board
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SwanseaUnited KingdomUnknown status
Hampshire Hospitals NHS Foundation Trust
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WinchesterUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.