A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen-Cilag Pharma GmbH
About this trial
The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration
Confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records
Must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements
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 receiving guselkumab in routine clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
35 Participants
are grouped into 1 trial groupGroup A: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
Trial outcomes
Primary outcomes
1
Persistence with Guselkumab Treatment
Persistence with guselkumab treatment is defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion. It will be used to measure the guselkumab persistence in participants.
Time frame
Up to Week 96Secondary outcomes
1
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
Number of participants with early responses to guselkumab measured using bowel urgency will be assessed via participant diaries.
Time frame
At Weeks 0 (baseline) 1, 2, 4, 8 and 122
Number of Participants with Early Responses to Guselkumab Measured Using Patient Reported Outcome (PRO-2) Components
Number of participants with early responses to guselkumab will be assessed using PRO-2 components and reported via participant diaries. Measurements captured include stool frequency, rectal bleeding, and abdominal pain.
Time frame
At Weeks 0 (baseline), 1, 2, 4, 8 and 123
Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) Score
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 reduction in HBI by greater than or equal to (\>=)3 points from baseline or achieving HBI less than or equal to (\<=) 4.
Time frame
At Weeks 12, 48 and 964
Number of Participants Achieving Clinical Response for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
PMS is used to assess disease severity and treatment effectiveness. The PMS comprises 3 categories: rectal bleeding, SF, and physician assessment. These are rated from 0-3 and are totaled to give a total score that ranges from 0-12. Higher score indicates severe disease. Clinical response for UC is defined as the PMS score less than (\<) 4 or \>= 30 percent (%) reduction from baseline.
Time frame
At Weeks 12, 48 and 96Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov