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Can a biologic drug tame Crohn's without steroids? a large Real-World study investigates

NCT ID NCT07748338

Disease control Sponsor: University Hospital Southampton NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study follows about 600 adults with Crohn's disease who are receiving ustekinumab (Stelara) as part of their routine care. The goal is to see how many achieve steroid-free remission after one year, using a standard symptom score. By including patients from both large research centers and smaller hospitals, the study aims to reflect real-world outcomes beyond clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ustekinumab (Stelara), a biologic drug given as an intravenous infusion followed by subcutaneous injections.
What this could lead to
If successful, this study could provide a clearer picture of how well ustekinumab works in everyday clinical practice, potentially guiding treatment decisions for Crohn's disease.
What could go wrong
As a real-world observational study, it doesn't prove cause and effect. Results may vary due to differences in patient populations and care settings, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

601 people

The number who actually took part.

Started

Oct 2019

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with an established diagnosis of Crohn's disease who have not previously received ustekinumab and meet the eligibility criteria.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

Contacts and locations

Locations

  • Barnsley Hospital NHS Foundation Trust

    Barnsley, South Yorkshire, S75 2EP, United Kingdom

  • Barts Health NHS Trust

    London, Greater London, E1 1BB, United Kingdom

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, West Yorkshire, BD9 6RJ, United Kingdom

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, Greater London, SW10 9NH, United Kingdom

  • Dorset County Hospital NHS Foundation Trust

    Dorchester, Dorset, DT1 2JY, United Kingdom

  • Guy's and St Thomas' NHS Foundation Trust

    London, Greater London, SE1 9RT, United Kingdom

  • Hampshire Hospitals NHS Foundation Trust

    Winchester, Hampshire, SO22 5DG, United Kingdom

  • Kingston Hospital NHS Foundation Trust

    Kingston, Greater London, KT2 7QB, United Kingdom

  • Lewisham and Greenwich NHS Trust

    London, Greater London, SE13 6LH, United Kingdom

  • Newcastle Hospitals NHS Foundation Trust

    Newcastle, Tyne and Wear, NE1 4LP, United Kingdom

  • Pennine Acute Hospitals NHS Trust

    Bury, Greater Manchester, BL9 7TD, United Kingdom

  • Royal United Hospitals Bath NHS Foundation Trust

    Bath, Somerset, BA1 3NG, United Kingdom

  • Salford Royal NHS Foundation Trust

    Salford, Greater Manchester, M6 8HD, United Kingdom

  • Salisbury NHS Foundation Trust

    Salisbury, Wiltshire, SP2 8BJ, United Kingdom

  • St George's Hospital

    London, Greater London, SW17 0QT, United Kingdom

  • St Mark's Hospital

    Harrow, Middlesex, HA1 3UJ, United Kingdom

  • Swansea Bay University Health Board

    Swansea, West Glamorgan, SA2 8QA, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • University Hospital of Wales, Cardiff

    Cardiff, South Glamorgan, CF14 4XW, United Kingdom

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, Bristol, BS2 8HW, United Kingdom

  • University Hospitals Dorset NHS Foundation Trust

    Bournemouth, Dorset, BH7 7DW, United Kingdom

  • University Hospitals Sussex

    Brighton, East Sussex, BN2 5NG, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.