CompletedNot Applicable

Ustekinumab Real World Evidence Study

United Kingdom601 participantsStarted 2019-10-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Steroid-free remission

Timeframe: One year

Trial details

NCT IDNCT07748338

SponsorUniversity Hospital Southampton NHS Foundation Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-20

View on ClinicalTrials.gov More Crohn's Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.