Crohn's DiseaseUndieSNCT07748338
Ustekinumab Real World Evidence Study
An observational study of Crohn's Disease, run by University Hospital Southampton NHS Foundation Trust at 22 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- How many people
- 601 participants
- Where
- 22 sitesUnited Kingdom
- Study dates
- 30 Oct 2019to 20 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an established diagnosis of Crohn's disease who have not previously received ustekinumab and meet the eligibility criteria.
Who may be able to join
- 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
Show all 10Show fewer
- Post-operative prophylaxis
- Age 18 or over
- Able to give informed consent
- Able to read English
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United Kingdom22 sites
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, S75 2EP
Royal United Hospitals Bath NHS Foundation Trust
Bath, Somerset, BA1 3NG
University Hospitals Dorset NHS Foundation Trust
Bournemouth, Dorset, BH7 7DW
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, BD9 6RJ
University Hospitals Sussex
Brighton, East Sussex, BN2 5NG
University Hospitals Bristol NHS Foundation Trust
Bristol, Bristol, BS2 8HW
Pennine Acute Hospitals NHS Trust
Bury, Greater Manchester, BL9 7TD
University Hospital of Wales, Cardiff
Cardiff, South Glamorgan, CF14 4XW
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, DT1 2JY
St Mark's Hospital
Harrow, Middlesex, HA1 3UJ
Kingston Hospital NHS Foundation Trust
Kingston, Greater London, KT2 7QB
Barts Health NHS Trust
London, Greater London, E1 1BB
Guy's and St Thomas' NHS Foundation Trust
London, Greater London, SE1 9RT
Lewisham and Greenwich NHS Trust
London, Greater London, SE13 6LH
Chelsea and Westminster Hospital NHS Foundation Trust
London, Greater London, SW10 9NH
St George's Hospital
London, Greater London, SW17 0QT
Newcastle Hospitals NHS Foundation Trust
Newcastle, Tyne and Wear, NE1 4LP
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD
Salisbury NHS Foundation Trust
Salisbury, Wiltshire, SP2 8BJ
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
Swansea Bay University Health Board
Swansea, West Glamorgan, SA2 8QA
Hampshire Hospitals NHS Foundation Trust
Winchester, Hampshire, SO22 5DG
About this study
Official title: UndieS: Ustekinumab Real World Evidence Study
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.
Read the detailed description
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. It will utilise existing research networks to deliver the study effectively. The UK IBD community has strongly demonstrated that it is both willing and able to work on collaborative projects, ranging from interventional trials (TOPPIC, CONSTRUCT) and prospective observational studies (PANTS, VEST), through to case finding studies (PRED4) as well as retrospective cohort studies (UK experience of withdrawal of thiopurines [PMID 25284134] and anti-TNF[PMID 26892328]) as well as the UK IBD BioResource. PANTS successfully recruited from 120 sites in the UK. The study will in part use the UK IBD Registry infrastructure to leverage the impact of the data. These collaborations have led to significant publications in high impact journals, and will impact directly on the management of IBD patients in the near future. Key to this successful work is the National Institute of Health Research (NIHR), which supports local Clinical Research Networks in the delivery of multicentre research.
- Conditions
- Crohn's Disease
- Being tested
- Ustekinumab
- Keywords
- Inflammatory Bowel Disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called Stelara
Intravenous baseline, subcutaneous follow ups.
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid-free remission
Steroid-free remission at one year as defined by a mHBI at week 56 of less than or equal to 4.
Measured: One year
Secondary outcomes (8)
Description of the demographics, disease phenotype, disease history, treatment history and concomitant medication use of patients receiving ustekinumab.
Collected from medical records and patient
Measured: Two years
Remission and response rates
Response to treatment as measured by modified Harvey Bradshaw Index (mHBI)
Measured: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Remission and response rates
Response to treatment as measured by Physician's Global Assessment (PGA)
Measured: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Remission and response rates
Response to treatment as measured by IBD Control PROM (Patient Reported Outcome Measures)
Measured: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Drug persistence
Enquiring of the patient whether they are still administering the treatment at each follow up visit
Measured: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Patient experience of ustekinumab as assessed by Treatment Satisfaction Questionnaire for Medication (TSQM)
Multiple choice questionnaire about patient's experience of using the medication
Measured: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Effect of ustekinumab on disease activity as measured by routinely collected biomarkers
Review of existing blood samples, and calprotectin results, done as part of routine care
Measured: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Tolerance and safety of ustekinumab
Review of adverse events as reported by the patient at each study visit
Measured: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start30 Oct 2019
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748338
- Sponsor's protocol ID
- RHM MED1651
- Acronym
- UndieS
- Status last verified
- Jul 2026
- First submitted
- 25 Jan 2021
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UndieS: Ustekinumab Real World Evidence Study
- ClinicalTrials.gov ID
- NCT07748338
- Acronym / sponsor ID
- UndieS / RHM MED1651
- Conditions
- Crohn's Disease
- Keywords
- Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. It will utilise existing research networks to deliver the study effectively. The UK IBD community has strongly demonstrated that it is both willing and able to work on collaborative projects, ranging from interventional trials (TOPPIC, CONSTRUCT) and prospective observational studies (PANTS, VEST), through to case finding studies (PRED4) as well as retrospective cohort studies (UK experience of withdrawal of thiopurines [PMID 25284134] and anti-TNF[PMID 26892328]) as well as the UK IBD BioResource. PANTS successfully recruited from 120 sites in the UK. The study will in part use the UK IBD Registry infrastructure to leverage the impact of the data. These collaborations have led to significant publications in high impact journals, and will impact directly on the management of IBD patients in the near future. Key to this successful work is the National Institute of Health Research (NIHR), which supports local Clinical Research Networks in the delivery of multicentre research.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an established diagnosis of Crohn's disease who have not previously received ustekinumab and meet the eligibility criteria.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabAlso: StelaraIntravenous baseline, subcutaneous follow ups. | Drug | – |
Primary outcome
Steroid-free remission
Time frame: One year
Steroid-free remission at one year as defined by a mHBI at week 56 of less than or equal to 4.
8 secondary outcomes
Description of the demographics, disease phenotype, disease history, treatment history and concomitant medication use of patients receiving ustekinumab.
Time frame: Two years
Remission and response rates
Time frame: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Remission and response rates
Time frame: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Remission and response rates
Time frame: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Drug persistence
Time frame: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Patient experience of ustekinumab as assessed by Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Effect of ustekinumab on disease activity as measured by routinely collected biomarkers
Time frame: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Tolerance and safety of ustekinumab
Time frame: Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by University Hospital Southampton NHS Foundation Trust at 22 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid-free remission (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.