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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD): Guselkumab | Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from clinical practice, through routine therapeutic procedures and evaluation assessments will be collected within this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Weeks 0, 1, 2, 4, 8, and 12 |
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Inclusion Criteria:
Exclusion criteria:
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The study population will include participants with confirmed diagnosis of moderate-to-severe crohn's disease (CD) or ulcerative colitis (UC) disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Salama Hospital | Recruiting | Jeddah | 23611 | Saudi Arabia |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D003092 | Colitis |
| D014456 | Ulcer |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
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| 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. | Weeks 0, 1, 2, 4, 8, and 12 |
| 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. | Weeks 0, 1, 2, 4, 8, and 12 |
| 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. | Weeks 12, 48 and 96 |
| Number of Participants Achieving Clinical Response for UC as Measured by Partial Mayo Score (PMS) | 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. | Weeks 12, 48 and 96 |
| Number of Participants Achieving Corticosteroid-free remission for UC | Participants Achieving Corticosteroid-free remission for UC will be reported. | Weeks 24, 48 and 96 |
| Number of Participants Achieving Corticosteroid-free remission for CD | Participants Achieving Corticosteroid-free remission for CD will be reported. | Weeks 24, 48 and 96 |
| Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC | 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. | Weeks 24, 48 and 96 |
| Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD | 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. | Weeks 24, 48 and 96 |
| Characteristics of Participants Receiving Guselkumab Treatment: Age | Age of participants receiving guselkumab treatment will be reported. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: Sex | Sex of participants receiving guselkumab treatment will be reported. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use | Number of participants using the previous inflammatory bowel disease (IBD) medication will be reported. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History | Number of participants with current and former smoking status receiving guselkumab treatment will be reported. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: Height | Height of participants receiving guselkumab treatment will be reported. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: Weight | Weight of participants receiving guselkumab treatment will be reported. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity | Number of participants reporting the disease severity will be assessed. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis | Participants age at diagnosis will be reported. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration | Participants disease duration will be reported. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses | Number of participants with Comorbid Diagnoses will be reported. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD | Number of participants with a history of UC/CD will be reported. | At Baseline |
| Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries | Number of participants who have undergone previous IBD-related surgeries will be reported. | At Baseline |
| Number of Participants with Adverse Events (AEs) | 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. | Up to Week 96 |
| Change in C-reactive protein (CRP) Levels | 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. | Week 0, 12, 48 and 96 |
| Change in Fecal Calprotectin (Fcal) Levels | 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. | Week 0, 12, 48 and 96 |
| Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment | Number of participants receiving concomitant IBD medications during guselkumab treatment will be reported. | Baseline up to Week 96 |
| Health-related Quality of Life As Assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score | 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. | Week 0, 12, 48 and 96 |
| Health-related Quality of life of Participants Receiving Guselkumab Treatment as Assessed by Bowel Urgency | Health-related Quality of life of participants receiving guselkumab treatment as assessed by bowel urgency will be reported. | Week 0, 12, 48 and 96 |
| Health-related Quality of Life of Participants Receiving Guselkumab Treatment as Assessed by PRO-2 Components | Health-related Quality of life of participants receiving guselkumab treatment as assessed by PRO-2 components will be reported. | Week 0, 12, 48 and 96 |
| Change from Baseline in Satisfaction with Guselkumab Treatment as per Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score | 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. | Week 0 (Baseline) , Weeks 12, 48 and 96 |
| Number of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD) | Endoscopic response is defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score <=4. | Week 0, 12, 48 and 96 |
| Number of Participants Achieving Endoscopic Remission in Participants with CD | 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. | Week 0, 12, 48 and 96 |
| Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score | Endoscopic Improvement is defined as a Mayo score <=1. | Week 0, 12, 48 and 96 |
| Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score | Endoscopic normalization is defined as a Mayo score =0. | Week 0, 12, 48 and 96 |
| Change in Number of UC/CD Emergency Room Visits | Change in the number of emergency room visits for treatment of UC/CD will be reported. | Week 0, 12, 48 and 96 |
| Change in Number of UC/CD-Hospitalizations | Change in the number of hospitalizations for treatment of UC/CD will be reported. | Week 0, 12, 48 and 96 |
| Change in Number of UC/CD Surgeries | Change in the number of surgeries for treatment of UC/CD will be reported. | Week 0, 12, 48 and 96 |
| D007410 |
| Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015212 | Inflammatory Bowel Diseases |