NCT07242248 A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
| NCT ID | NCT07242248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Janssen-Cilag Ltd. |
| Condition | Inflammatory Bowel Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2029-03-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2025-11-17 with a primary completion date of 2029-03-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.
Eligibility Criteria
Inclusion Criteria: * Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug. Decision to prescribe must solely be made by the treating physician in line with the Trust's/ Health Board's treatment guidance. Enrolment must take place before or at the day of first administration (but after treatment decision by physician) * Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records * Must sign a informed consent form (ICF) allowing source data verification in accordance with local requirements Exclusion Criteria: * Contraindicated to guselkumab per the label * Is currently enrolled in an interventional clinical study * Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi ® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included * Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and /or small molecules) * Is unable to provide informed consent
Contact & Investigator
Janssen-Cilag Limited Clinical Trial
STUDY DIRECTOR
Janssen-Cilag Limited
Frequently Asked Questions
Who can join the NCT07242248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07242248 currently recruiting?
Yes, NCT07242248 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07242248 trial being conducted?
This trial is being conducted at Harrow, United Kingdom.
Who is sponsoring the NCT07242248 clinical trial?
NCT07242248 is sponsored by Janssen-Cilag Ltd.. The principal investigator is Janssen-Cilag Limited Clinical Trial at Janssen-Cilag Limited. The trial plans to enroll 220 participants.