Colitis, Crohn Disease, Ulcerative
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * Is unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Guselkumab Discontinuation | Up to Week 96 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD) | Week 0, 12, 48 and 96 | Endoscopic response is defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score \<=4. |
| Number of Participants Achieving Endoscopic Remission in Participants with CD | Week 0, 12, 48 and 96 | Endoscopic remission in participants with CD is defined as SES-CD total score \<= 4 with at least 2 points reduction from baseline and no subscore greater than (\>)1 in any individual component. |
| Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score | Week 0, 12, 48 and 96 | Endoscopic Improvement is defined as a Mayo score \<=1. |
| Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score | Week 0, 12, 48 and 96 | Endoscopic normalization is defined as a Mayo score =0. |
| Change in Number of UC/CD Emergency Room Visits | Week 0, 12, 48 and 96 | Change in the number of emergency room visits for treatment of UC/CD will be reported. |
| Change in Number of UC/CD-Hospitalizations | Week 0, 12, 48 and 96 | Change in the number of hospitalizations for treatment of UC/CD will be reported. |
| Change in Number of UC/CD Surgeries | Week 0, 12, 48 and 96 | Change in the number of surgeries for treatment of UC/CD will be reported. |
| Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components for Crohn's Disease (CD) | Weeks 0, 1, 2, 4, 8, and 12 | 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). |
| Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components for Ulcerative Colitis (UC) | Weeks 0, 1, 2, 4, 8, and 12 | 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. |
| Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency | Weeks 0, 1, 2, 4, 8, and 12 | 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. |
| Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) | Weeks 12, 48 and 96 | 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. |
| Number of Participants Achieving Clinical Response for UC as Measured by Partial Mayo Score (PMS) | Weeks 12, 48 and 96 | Mayo scoring system 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. Clinical response for UC is defined as the PMS score less than (\<) 4 or \>= 30 percent (%) reduction from baseline. |
| Number of Participants Achieving Corticosteroid-free remission for UC | Weeks 24, 48 and 96 | Participants Achieving Corticosteroid-free remission for UC will be reported. |
| Number of Participants Achieving Corticosteroid-free remission for CD | Weeks 24, 48 and 96 | Participants Achieving Corticosteroid-free remission for CD will be reported. |
| Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC | Weeks 24, 48 and 96 | Corticosteroid-free PRO-2 remission in UC participants is defined as a SF score of 0 or 1, where it has not increased from baseline, and a rectal bleeding sub score of 0 with no use of steroids for at least 30 days. |
| Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD | Weeks 24, 48 and 96 | Corticosteroid-free PRO-2 remission in CD participants is defined as an AP score less than or equal to (\<=)1 and a mean SF score \<=3 and no worsening of AP or SF compared with baseline and no use of steroids for at least 30 days. |
| Characteristics of Participants Receiving Guselkumab Treatment: Age | At Baseline | Age of participants receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Sex | At Baseline | Sex of participants receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use | At Baseline | Number of participants using the previous inflammatory bowel disease (IBD) medication will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History | At Baseline | Number of participants with current and former smoking status receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Height | At Baseline | Height of participants receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Weight | At Baseline | Weight of participants receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity | At Baseline | Number of participants reporting the disease severity will be assessed. |
| Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis | At Baseline | Participants age at diagnosis will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration | At Baseline | Participants disease duration will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses | At Baseline | Number of participants with Comorbid Diagnoses will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD | At Baseline | Number of participants with a history of UC/CD will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries | At Baseline | Number of participants who have undergone previous IBD-related surgeries will be reported. |
| Number of Participants with Adverse Events (AEs) | Up to Week 96 | An adverse event is any untoward medical occurrence in a participant administered a medicinal product based on appropriate medical judgment. An AE does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. |
| Change in C-reactive protein (CRP) Levels | Week 0, 12, 48 and 96 | Change in CRP levels since guselkumab initiation will be reported. C-reactive protein is a marker of inflammation that will be measured by physicians following routine clinical practice. |
| Change in Fecal Calprotectin (Fcal) Levels | Week 0, 12, 48 and 96 | Change in Fcal levels since guselkumab initiation will be reported. The Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice. |
| Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment | Baseline up to Week 96 | Number of participants receiving concomitant IBD medications during guselkumab treatment will be reported. |
| Health-related Quality of Life As Assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score | Week 0, 12, 48 and 96 | SIBDQ is a HRQoL tool measuring physical, social, and emotional status in IBD patients 45. The SIBDQ is a 10-item survey measuring HRQoL over the last 2 weeks (frequency of bowel movement, abdominal cramps, fatigue, lack of energy, worry of surgery, fear of no toilet, ability to relax, irritable, impact on leisure, impact on intimacy). The total score ranges from 10 to 70, where high score indicates better QoL. |
| Health-related Quality of life of Participants Receiving Guselkumab Treatment as Assessed by Bowel Urgency | Week 0, 12, 48 and 96 | Health-related Quality of life of participants receiving guselkumab treatment as assessed by bowel urgency will be reported. |
| Change from Baseline in Satisfaction with Guselkumab Treatment as per Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score | Week 0 (Baseline) , Weeks 12, 48 and 96 | TSQM-9 is an abbreviated version of the 14-item TSQM, and is a reliable and valid measure to assess treatment satisfaction. It consists of 9 items distributed in the domains: side effects, effectiveness, convenience, and global satisfaction, with scores at each domain ranging from 0 to 100. Higher score indicating higher treatment satisfaction. |
| Health-related Quality of Life of Participants Receiving Guselkumab Treatment as Assessed by PRO-2 Components | Week 0, 12, 48 and 96 | Health-related Quality of life of participants receiving guselkumab treatment as assessed by PRO-2 components will be reported. |
Countries
Saudi Arabia
Contacts
CONTACTStudy Contact
Outcome results
None listed