A Study of Long Term Persistency of Guselkumab in Adult Participants With Inflammatory Bowel Disease

N/ANot Yet RecruitingNCT07822529

Janssen Research & Development, LLC400 enrolled

Overview

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 diseases, a group of inflammatory conditions of the colon and small intestine.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Inflammatory Bowel Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Must be greater than or equal to (\>=) 18 years old * 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 the 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 (but after treatment decision by physician) * Must have a confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative Colitis (UC) recorded in their medical records * Participant has received the information note/given his/her oral agreement and has not objected to the collection of their data 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 a prior history of Stelara (ustekinumab) and biosimilars exposure, may be included * History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)

Outcomes

Primary Outcomes

Persistence with Guselkumab Treatment

Time to guselkumab discontinuation will be used to measure the guselkumab persistence in participants and is defined as the time from the first administration of guselkumab to its discontinuation date (defined as the date that the last dose of treatment was administered plus 1 dosing interval).

Time frame: Up to Week 96

Secondary Outcomes

Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency

Number of participants with early responses to guselkumab measured via bowel urgency will be assessed via participant diaries.

Time frame: At Weeks 0, 1, 2, 4, 8, 12

Number of Participants with Early Responses to Guselkumab Measured Using Simplified Patient-Reported Outcome (2-item) (PRO-2) Components in Participants with CD

Number of participants with early responses to guselkumab will be assessed via participant diaries. Measurements captured for CD include stool frequency and abdominal pain (AP).

Time frame: At Weeks 0, 1, 2, 4, 8, 12

Number of Participants with Early Responses to Guselkumab Measured Using Simplified Patient-Reported Outcome (2-item) (PRO-2) Components in Participants with UC

Number of participants with early responses to guselkumab will be assessed via participant diaries. Measurements captured for UC include rectal bleeding and stool frequency (SF).

Time frame: At Weeks 0, 1, 2, 4, 8, 12

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. Efficacy will be evaluated by line of treatment and subpopulation.

Central Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

Data from ClinicalTrials.gov

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Time frame: Up to Week 96

Number of Participants Achieving Clinical Remission for CD as Measured by HBI Score

Clinical remission for CD is defined as a HBI score of \<= 4. Efficacy will be evaluated by line of treatment and subpopulation.

Time frame: Up to Week 96

Number of Participants Achieving Corticosteroid-Free Clinical Response for CD as Measured by HBI Score

Corticosteroid-free clinical response for CD is defined as the reduction in HBI \>=3 points from baseline or achieving HBI \<=4 with no use of corticosteroids for at least 30 days. Efficacy will be evaluated by line of treatment and subpopulation.

Time frame: Up to Week 96

Number of Participants Achieving Corticosteroid-Free Clinical Remission for CD

Corticosteroid-free clinical remission will be defined as a HBI score of \<= 4 and no use of corticosteroids for at least 30 days in participants with CD. Efficacy will be evaluated by line of treatment and subpopulation.

Time frame: Up to Week 96

Number of Participants Achieving Clinical Response for Ulcerative Colitis (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 summed 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. Efficacy will be evaluated by line of treatment and subpopulation.

Time frame: Up to Week 96

Number of Participants Achieving Clinical Remission for UC as Measured by PMS

Clinical remission for UC is defined as the PMS score \< 2 and a rectal bleeding subscore of 0. Efficacy will be evaluated by line of treatment and subpopulation.

Time frame: Up to Week 96

Number of Participants Achieving Corticosteroid-Free Clinical Response for UC as Measured by PMS

Corticosteroid free clinical response is defined as a PMS score of \<4 or \>=30% reduction from baseline and no use of corticosteroids for at least 30 days. Efficacy will be evaluated by line of treatment and subpopulation.

Time frame: Up to Week 96

Number of Participants Achieving Corticosteroid-Free Clinical Remission for UC

Corticosteroid-free clinical remission will be defined as a PMS score of less than (\<)2, no use of corticosteroids for at least 30 days and a rectal bleeding subscore of 0 in participants with UC. Efficacy will be evaluated by line of treatment and subpopulation.

Time frame: Up to Week 96

Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD

The CD PRO-2 consists of 2 items: abdominal pain and stool frequency. An AP score \<=1 and a mean SF score \<=3 and no worsening of AP or SF compared with baseline and no use of corticosteroids for at least 30 days in CD participants will be defined as a corticosteroid-free PRO-2 remission. Efficacy will be evaluated by line of treatment and subpopulation.

Time frame: Up to Week 96

Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC

The UC PRO-2 is composed of rectal bleeding and stool frequency. An SF subscore of 0 or 1, where it has not increased from baseline, and a PMS rectal bleeding subscore of 0 with no use of corticosteroids for at least 30 days in UC participants will be defined as a corticosteroid-free PRO-2 remission. Efficacy will be evaluated by line of treatment and subpopulation.

Time frame: Up to Week 96

Characteristics of Participants Receiving Guselkumab Treatment: Age

Age of participants receiving guselkumab treatment will be reported.

Time frame: At Baseline

Characteristics of Participants Receiving Guselkumab Treatment: Sex

Sex of participants receiving guselkumab treatment will be reported.

Time frame: At Baseline

Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Usage

The number and type of previous inflammatory bowel disease (IBD) medication used by participant will be reported.

Time frame: 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.

Time frame: At Baseline

Characteristics of Participants Receiving Guselkumab Treatment: Height

Height of participants receiving guselkumab treatment will be reported.

Time frame: At Baseline

Characteristics of Participants Receiving Guselkumab Treatment: Weight

Weight of participants receiving guselkumab treatment will be reported.

Time frame: At Baseline

Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity At Index

Disease severity per participant at baseline will be assessed.

Time frame: At Baseline

Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis

Participant's age at diagnosis will be reported.

Time frame: At Baseline

Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration

Participants disease duration will be reported.

Time frame: At Baseline

Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses

Number and nature of comorbidities per participant will be reported.

Time frame: At Baseline

Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD

Number of participants with history of UC/CD will be reported.

Time frame: At Baseline

Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries

Number of participants who have undergone previous IBD-related surgeries and the nature of surgeries will be reported.

Time frame: At Baseline

Number of Participants with Adverse Events (AE)

An adverse event is any untoward medical occurrence in a participant administered a medicinal product. An adverse event 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.

Time frame: 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.

Time frame: Up to Week 96

Change in Fecal Calprotectin (Fcal) Levels

Change in Fcal levels since guselkumab initiation will be reported. Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice where higher values indicate greater intestinal inflammation.

Time frame: Up to Week 96

Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment

Number of participants with concomitant IBD medications and the type of concomitant medications given during guselkumab treatment will be reported.

Time frame: Up to Week 96

Health-related Quality of Life As Assessed by Short IBD Questionnaire (SIBDQ) Total Score

The SIBDQ is a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status in IBD participants. 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.

Time frame: Up to Week 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.

Time frame: Up to Week 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.

Time frame: Up to Week 96

Functional Assessment Of Chronic Illness (FACIT) Fatigue (FACIT-F) Scale Score

The FACIT-F scale is a 13-item instrument designed to assess fatigue/tiredness and its impact on daily activities and functioning in chronic diseases. The instrument includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning over the last 7 days. Scores are numeric and range from 0 to 52 with higher scores indicating less fatigue.

Time frame: Up to Week 96

Number of CD Participants Achieving Endoscopic Response 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. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease. If SES-CD is not available, response is defined as a reduction in ulcer size, number or extend on endoscopy compared to baseline.

Time frame: Up to Week 96

Number of Participants Achieving Endoscopic Remission in Participants with CD

Endoscopic remission is defined as SES -CD total score \<= 4 with at least 2 points reduction from baseline and no subscore \>1 in any individual component . SES-CD score can range from 0 to 56. Higher scores indicating more severe disease. If SES-CD is not available, response is defined as an absence of mucosal ulcers as seen on endoscopy.

Time frame: Up to Week 96

Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score

Endoscopic improvement is defined as Mayo score \<=1. The Mayo Clinic Score is a composite index with total score ranging from 0 to 12. Higher scores indicate worse disease activity.

Time frame: Up to Week 96

Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score

Endoscopic normalization is defined as Mayo score =0. The Mayo Clinic Score is a composite index with a total score ranging from 0 to 12. Higher scores indicate worse disease activity.

Time frame: Up to Week 96

Number of Participants Achieving Histological Improvement in Participants with UC as Measured by Nancy Score

Histological improvement defined by a reduction in the Nancy score by at least one point compared to baseline will be reported. The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease).

Time frame: Up to Week 96

Number of Participants Achieving Histological Remission in Participants with UC as Measured by Nancy Score

Histological remission defined by a Nancy score of 0 or 1 will be reported. The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease).

Time frame: Up to Week 96

Number of Participants Achieving Intestinal Utrasound (IUS) Response in Participants with CD as Measured by Bowel Wall Thickness (BWT)

IUS response is defined as reduction of BWT of \>=25% or normalization (\<=3 millimeters \[mm\]) of the most affected segment at Weeks 24, 48, 72, 96 in participants with increased BWT (\>3 mm) at baseline.

Time frame: At Weeks 24, 48, 72, 96

Number of Participants Achieving IUS (Transmural) Remission in Participants with CD as Measured by BWT

IUS remission is defined as normalization of BWT (\<=3 mm) and vascularity (no signal or short signal in color Doppler of the most affected segment) at Weeks 24, 48, 72, 96, in participants with increased BWT (\> 3 mm) at baseline

Time frame: At Weeks 24, 48, 72, 96

Number of Participants Achieving Magnetic Resonance Enterography (MRE) Response in Participants with CD

MRE response is defined as improvement of bowel wall thickness and contrast enhancement compared to baseline.

Time frame: Up to Week 96

Number of Participants Achieving MRE Remission in Participants with CD

MRE remission is defined as bowel wall thickness \<=3 mm without segmental mural hyperenhancement.

Time frame: Up to Week 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. t 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. Here, higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.

Time frame: Baseline, Weeks 12, 48, and 96

Change from Baseline in Number of UC/CD Emergency Room Visits

Change in the number of emergency room visits for treatment of UC/CD will be reported.

Time frame: Baseline, Weeks 12, 48, 96

Change from Baseline in Number of UC/CD Hospitalizations

Change in the number of hospitalizations for treatment of UC/CD will be reported.

Time frame: Baseline, Weeks 12, 48, 96

Change from Baseline in Number of UC/CD Surgeries

Change in the number of surgeries for treatment of UC/CD will be reported.

Time frame: Baseline, Weeks 12, 48, 96