Clinical Trials in Spain / NCT07848737
Starting soon
Observational
A Real-World Study of Guselkumab Persistence and Effectiveness in Participants With Crohn's Disease or Ulcerative Colitis
NCT07848737 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Colitis, UlcerativeCrohn Disease
Study summary
The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).
Eligibility
Inclusion criteria:
* Participant 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. Participant must have been at least 8 weeks under guselkumab treatment before being included in the study, regardless if they are still on guselkumab treatment or not
* Participant must have a confirmed diagnosis of moderate-to-severe or Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records: Harvey-Bradshaw Index (HBI) greater than (\>)4 for CD and Partial Mayo Score (pMS)\>2 for UC
* Participant \[and/or their legally-acceptable representative where applicable\] must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements
Exclusion criteria:
* Contraindicated to guselkumab per the label
* It 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
* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
* Is unable to provide the ICF
Primary outcome measure(s)
- Persistence of Treatment with Guselkumab — Up to 96 weeks
Persistence of treatment with guselkumab will be measured through time to guselkumab discontinuation defined as the time at which the next infusion should have taken place for a participant after their last scheduled infusion.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hosp. Clinico Univ. de Santiago | Santiago de Compostela | Spain |
Other trials for the same condition
De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease
Enrolling by invitation
The CROCO Study: CROhn's Disease COhort Study
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07848737 on ClinicalTrials.gov ↗ ← All trials in Spain