Back to search
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
Colitis, Ulcerative
Crohn's Disease
Inflammatory Bowel Disease
Clinicaltrials.gov:
Other:
#CNTO1959IBD4006
Interested in this trial?
Subscribe or share this trial
Trials at a glance
Status
Enrolling
Condition
Colitis, Ulcerative
Crohn's Disease
Inflammatory Bowel Disease
Trial type
Observational
Trial phase
N/A
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
November 17, 2025
Trial end date
March 17, 2029
CT.gov ID
#NCT07242248
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
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.
Primary outcome measures
- Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
- Number of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
- Number of Participants Achieving Clinical Response for CD as Measured by HBI
- Number of Participants Achieving Clinical Response for UC as Measured by PMS
- Number of Participants Achieving Corticosteroid-free Remission for CD as Measured by HBI
- Number of Participants Achieving Corticosteroid-free Remission for UC as Measured by PMS
- Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI
- Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS
- Number of Participants Achieving Patient-Reported Outcome (PRO)-2 Corticosteroid-Free Remission for CD as Measured by HBI
- Number of Participants Achieving PRO-2 Corticosteroid-Free Remission for UC as Measured by PMS
Secondary outcome measures
- Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for UC
- Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for CD
- Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
- Time to Guselkumab Persistence
- Characteristics of Participants Receiving Guselkumab Treatment: Age
- Characteristics of Participants Receiving Guselkumab Treatment: Sex
- Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD Medication Use, Smoking Status and History, History of UC and History of CD
- Characteristics of Participants Receiving Guselkumab Treatment: Height
- Characteristics of Participants Receiving Guselkumab Treatment: Weight
- Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity
- Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis
- Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
- Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses
- Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries
- Number of Participants with Adverse Events (AEs)
- Change in C-reactive protein (CRP) Levels
- Number of Participants with CRP Normalization
- Change in Faecal Calprotectin (Fcal) Levels
- Number of Participants with Fcal Normalization
- Change in Albumin Levels
- Change in Hemoglobin Levels
- Change in Platelets Levels
- Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment
- Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score
- HRQoL as Measured by Bowel Urgency
- HRQoL as Measured by PRO-2 Components for Participants with CD
- HRQoL as Measured by PRO-2 Components for Participants with UC
- HRQoL as Measured by IBD-Control Questionnaire (ICHOM)
- Fatigue Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Scale
- Number of Participants Achieving Endoscopic Response for Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD)
- Number of Participants Achieving Endoscopic Remission for Participants with CD as Measured by SES-CD
- Number of Participants Achieving Endoscopic Improvement for Participants with UC as Measured by Mayo Score
- Number of Participants Achieving Endoscopic Normalization for Participants with UC as Measured by Mayo Score
- Number of Participants Achieving Histologic Improvement
- Number of Participants Achieving Histologic Remission
- Number of Participants with CD Achieving Intestinal Ultrasound (IUS) Response
- Number of Participants with CD Achieving IUS Remission
- Change from Baseline in Satisfaction with Guselkumab Treatment Using Treatment Satisfaction Questionnaire for Medication (TSQM)
- Change in Number of UC/CD Emergency Room Visits
- Change in Number of UC/CD-Hospitalizations
- Change in Number of UC/CD Surgeries
Access detailed information on the trial:
Clinical trials information
© Johnson & Johnson and its affiliates 2026
