Ustekinumab Real World Evidence Study
UndieS
UndieS: Ustekinumab Real World Evidence Study
1 other identifier
observational
601
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2019
CompletedFirst Submitted
Initial submission to the registry
January 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2026
CompletedAugust 5, 2026
July 1, 2026
5.4 years
January 25, 2021
August 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Steroid-free remission
Steroid-free remission at one year as defined by a mHBI at week 56 of less than or equal to 4.
One year
Secondary Outcomes (8)
Description of the demographics, disease phenotype, disease history, treatment history and concomitant medication use of patients receiving ustekinumab.
Two years
Remission and response rates
Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Remission and response rates
Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Remission and response rates
Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Drug persistence
Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
- +3 more secondary outcomes
Interventions
Eligibility Criteria
Patients with an established diagnosis of Crohn's disease who have not previously received ustekinumab and meet the eligibility criteria.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
University Hospitals Bristol NHS Foundation Trust
Bristol, Bristol, BS2 8HW, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Bournemouth, Dorset, BH7 7DW, United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, DT1 2JY, United Kingdom
University Hospitals Sussex
Brighton, East Sussex, BN2 5NG, United Kingdom
Kingston Hospital NHS Foundation Trust
Kingston, Greater London, KT2 7QB, United Kingdom
Barts Health NHS Trust
London, Greater London, E1 1BB, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, Greater London, SE1 9RT, United Kingdom
Lewisham and Greenwich NHS Trust
London, Greater London, SE13 6LH, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, Greater London, SW10 9NH, United Kingdom
St George's Hospital
London, Greater London, SW17 0QT, United Kingdom
Pennine Acute Hospitals NHS Trust
Bury, Greater Manchester, BL9 7TD, United Kingdom
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Winchester, Hampshire, SO22 5DG, United Kingdom
St Mark's Hospital
Harrow, Middlesex, HA1 3UJ, United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Bath, Somerset, BA1 3NG, United Kingdom
University Hospital of Wales, Cardiff
Cardiff, South Glamorgan, CF14 4XW, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, S75 2EP, United Kingdom
Newcastle Hospitals NHS Foundation Trust
Newcastle, Tyne and Wear, NE1 4LP, United Kingdom
Swansea Bay University Health Board
Swansea, West Glamorgan, SA2 8QA, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
Salisbury NHS Foundation Trust
Salisbury, Wiltshire, SP2 8BJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2021
First Posted
August 5, 2026
Study Start
October 30, 2019
Primary Completion
March 20, 2025
Study Completion
March 20, 2025
Last Updated
August 5, 2026
Record last verified: 2026-07