ClinicalTrials.gov
Cure8 trial brief
Ustekinumab Real World Evidence Study
Research and clinical trials
Ustekinumab
IL-12/23 inhibitor
Fecal calprotectin
CRP
Phase 3 clinical trial
Adult patients
Clinicians
Why This Matters
Real‑world studies of ustekinumab help patients and clinicians understand how the drug performs outside clinical trials, including effectiveness for steroid‑free remission and use across different UK care settings.
Findings could inform expectations about one‑year outcomes for adults with Crohn’s disease starting ustekinumab.
Who Should Pay Attention
Adults with Crohn’s disease considering or receiving ustekinumab; clinicians managing biologic therapy; researchers and registry teams interested in real‑world biologic outcomes.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment601 participants
Study statusCompleted
Source depthTrial registry record
What To Know
This is a completed, observational UK registry study that collected real‑world outcomes in adults with Crohn’s disease treated with ustekinumab during routine care. Planned enrollment was 601; the primary outcome was steroid‑free remission at one year (mHBI ≤4 at week 56).
Eligibility included adults starting ustekinumab for active disease or other clinical indications; baseline IV induction with subcutaneous maintenance was the regimen described. The study leveraged UK IBD Registry infrastructure and multiple NHS hospital sites for data capture.
The record reports study design, eligibility, intervention route, primary outcome measure and time frame but does not provide results in this registry entry. This brief summarizes the trial record information rather than published study findings.
Keep In Mind
This ClinicalTrials.gov record is a trial registry entry (observational, completed) and does not include published results in the provided text. The study measured steroid‑free remission at one year using the modified Harvey‑Bradshaw Index (mHBI); registry entries may be updated with results later or linked to publications.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorUniversity Hospital Southampton NHS Foundation Trust
Trial IDNCT07748338
Study typeObservational
Enrollment601 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 5, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
Current and novel biomarkers for predicting and assessing therapeutic response in inflammatory bowel disease: a systematic review.
People with IBD and their clinicians want ways to predict which advanced therapy will work best. This review summarizes current evidence and shows that, despite many studies, no biomarker is reliably ready for routine...
Beyond Anti-TNF: Is Ustekinumab a Better Choice in Crohn's? - Medscape
Patients considering switching biologics or clinicians choosing a second‑line therapy may care because the study suggests ustekinumab had better long‑term persistence and improving remission rates compared with anti‑TNF...
Ustekinumab Dose Intensification in Crohn's Disease - Docwire News
This trial directly tests common clinical strategies for managing loss of response to ustekinumab in Crohn’s disease. The findings may change whether doctors routinely escalate to 4-weekly dosing after an IV reinduction,...