ClinicalTrials.gov
Cure8 trial brief
Why This Matters
People with moderate-to-severe Crohn's disease or ulcerative colitis and their clinicians may want to know how long patients stay on guselkumab in real-world care, since persistence reflects tolerability, benefit, and treatment patterns outside trials.
Who Should Pay Attention
Adults with Crohn's disease or ulcerative colitis, patients considering or already on guselkumab, clinicians managing biologic therapy, and researchers studying real-world biologic use.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment35 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This is a non-interventional, registry-style study planned to enroll about 35 adults treated with guselkumab per approved labeling; no drug is supplied by the study. The primary outcome is time to guselkumab discontinuation (up to 96 weeks) measured from medical records and routine clinical data.
The study excludes people previously exposed to IL-23 inhibitors (including guselkumab, risankizumab, mirikizumab) though prior ustekinumab exposure is allowed as an exception. Participants currently in interventional trials or with >4 prior advanced IBD therapy lines are not eligible.
How to interpret this record Because this is an observational, not-yet-recruiting study record from ClinicalTrials.gov sponsored by Janssen, it will describe real-world persistence with guselkumab rather than randomized efficacy results. The record does not report outcomes or results yet.
Keep In Mind
This is a registered observational study (not yet recruiting) that will collect only routine clinical data and medical records; it does not administer study drug and will not produce randomized comparative evidence. As a trial record, it describes planned data collection and eligibility rather than results.
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
SponsorJanssen Sciences Ireland UC
Trial IDNCT07746765
Study typeObservational
Enrollment35 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.
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