Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Study Overview
Brief Summary
The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements
- •By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study
Exclusion Criteria
- •Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy
- •Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included
- •Has had a colectomy and/or a pouch
- •Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson & Johnson (J&J)
Arms & Interventions
Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. Only data available from clinical routine will be collected in this study. During the observational period, data will be collected at weeks 0 (baseline), 4, 8, 12, 24, 48, 72, and 96, where available as per clinical routine. The respective collection times relate to the first study dose of guselkumab.
Outcomes
Primary Outcomes
Percentage of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Time Frame: Week 48
Clinical remission for CD is defined as the HBI score less than or equal to (\<=) 4. HBI score is used to assess disease severity and treatment effectiveness.
Percentage of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
Time Frame: Week 48
Clinical remission for UC is defined as the PMS score \<=2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.
Secondary Outcomes
- Change in Bowel Urgency and Nocturnal Bowel Movement (NBM) Within the First 4 Weeks of Guselkumab Administration(Up to Week 4)
- Percentage of Participants Achieving Clinical Remission for UC as Measured by PMS(Up to Week 96)
- Time to Guselkumab Discontinuation(Up to Week 96)
- Change in Rectal Bleeding Within First 4 Weeks of Guselkumab Administration(Up to Week 4)
- Percentage of Participants Achieving Clinical Response for CD as Measured by HBI(Up to Week 96)
- Percentage of Participants Achieving Clinical Remission for CD as Measured by HBI(Up to Week 96)
- Change in Stool Frequency Within the First 4 Weeks of Guselkumab Administration(Up to Week 4)
- Change in Abdominal Pain Within the First 4 Weeks of Guselkumab Administration(Up to Week 4)
- Percentage of Participants Achieving Corticosteroid-free Clinical Remission for CD as Measured by HBI(Up to Week 96)
- Percentage of Participants Achieving Corticosteroid-free Clinical Remission for UC as Measured by PMS(Up to Week 96)
- Percentage of Participants Achieving Clinical Response for UC as Measured by PMS(Up to Week 96)
- Percentage of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI(Up to Week 96)
- Percentage of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS(Up to Week 96)
- Percentage of Participants with C-reactive Protein (CRP) Less Than or Equal to 5 milligram/litre (mg/L)(Up to Week 96)
- Change in CRP Levels(Up to Week 96)
- Percentage of Participants with Fecal Calprotectin (fCAL) Levels Less Than or Equal to 250 microgram/gram (mcg/g)(Up to Week 96)
- Change in fCAL Levels(Up to Week 96)
- Change in Hemoglobin Levels(Up to Week 96)
- Change in Transferrin Saturation(Up to Week 96)
- Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by IBD Symptoms(Baseline up to Week 96)
- Change from Baseline in General Quality of Life Measured by Short Health Scale (SHS) Score(Baseline up to Week 96)
- Change from Baseline in IBD-Specific Quality of Life Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score(Baseline up to Week 96)
- Change from Baseline in Fatigue Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Score(Baseline up to Week 96)
- Change from Baseline in Treatment Satisfaction Measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Scores(Baseline up to Week 96)
- Change from Baseline in Work Productivity and Activity Impairment Measured by Work Productivity and Activity Impairment (WPAI) Questionnaire(Baseline up to Week 96)
- Change from Baseline in Sexuality Measured by Intimacy and Sexuality Questionnaire (ISQ)-IBD(Baseline up to Week 96)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 108)
- Number of Participants with Special Situations(Up to Week 108)