A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC
About this trial
The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent
The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
The participant must sign a participation agreement/informed consent form (ICF) allowing source data verification
Disqualifiers
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
History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
Trial population
The study population will include participants with confirmed diagnosis of moderate-to-severe crohn's disease (CD) or ulcerative colitis (UC) disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD): Guselkumab
Trial outcomes
Primary outcomes
1
Time to Guselkumab Discontinuation
Time to guselkumab discontinuation is defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion.
Time frame
Up to Week 96Secondary outcomes
1
Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components for Crohn's Disease (CD)
Number of participants with early responses to guselkumab will be assessed using PRO-2 components for CD. Measurements captured include abdominal pain (AP) and stool frequency (SF).
Time frame
Weeks 0, 1, 2, 4, 8, and 122
Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components for Ulcerative Colitis (UC)
Number of participants with early responses to guselkumab will be assessed using PRO-2 components for UC. Measurements captured include rectal bleeding and stool frequency.
Time frame
Weeks 0, 1, 2, 4, 8, and 123
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
Number of participants with early responses to guselkumab will be assessed using bowel urgency. Bowel urgency from participants will be asked as yes or no outcome.
Time frame
Weeks 0, 1, 2, 4, 8, and 124
Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI)
HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical response for CD is defined as the HBI score less than or equal to (\<=) 4 or a decrease in HBI by greater than or equal to (\>=) 3 from baseline.
Time frame
Weeks 12, 48 and 96Sponsors and contacts
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Source ClinicalTrials.gov