Inflammatory Bowel Diseases
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 diseases, 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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistence with Guselkumab Treatment | Up to Week 96 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency | At Weeks 0, 1, 2, 4, 8, 12 | Number of participants with early responses to guselkumab measured via bowel urgency will be assessed via participant diaries. |
| Number of Participants with Early Responses to Guselkumab Measured Using Simplified Patient-Reported Outcome (2-item) (PRO-2) Components in Participants with CD | At Weeks 0, 1, 2, 4, 8, 12 | 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). |
| Number of Participants with Early Responses to Guselkumab Measured Using Simplified Patient-Reported Outcome (2-item) (PRO-2) Components in Participants with UC | At Weeks 0, 1, 2, 4, 8, 12 | 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). |
| Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) Score | Up to Week 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 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. |
| Number of Participants Achieving Clinical Remission for CD as Measured by HBI Score | Up to Week 96 | Clinical remission for CD is defined as a HBI score of \<= 4. Efficacy will be evaluated by line of treatment and subpopulation. |
| Number of Participants Achieving Corticosteroid-Free Clinical Response for CD as Measured by HBI Score | Up to Week 96 | 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. |
| Number of Participants Achieving Corticosteroid-Free Clinical Remission for CD | Up to Week 96 | 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. |
| Number of Participants Achieving Clinical Response for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS) | Up to Week 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 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. |
| Number of Participants Achieving Clinical Remission for UC as Measured by PMS | Up to Week 96 | 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. |
| Number of Participants Achieving Corticosteroid-Free Clinical Response for UC as Measured by PMS | Up to Week 96 | 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. |
| Number of Participants Achieving Corticosteroid-Free Clinical Remission for UC | Up to Week 96 | 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. |
| Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD | Up to Week 96 | 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. |
| Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC | Up to Week 96 | 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. |
| 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 Usage | At Baseline | The number and type of previous inflammatory bowel disease (IBD) medication used by participant 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 Index | At Baseline | Disease severity per participant at baseline will be assessed. |
| Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis | At Baseline | Participant's 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 and nature of comorbidities per participant will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD | At Baseline | Number of participants with 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 and the nature of surgeries will be reported. |
| Number of Participants with Adverse Events (AE) | Up to Week 96 | 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. |
| Change in C-Reactive Protein (CRP) Levels | Up to Week 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 | Up to Week 96 | 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. |
| Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment | Up to Week 96 | Number of participants with concomitant IBD medications and the type of concomitant medications given during guselkumab treatment will be reported. |
| Health-related Quality of Life As Assessed by Short IBD Questionnaire (SIBDQ) Total Score | Up to Week 96 | 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. |
| Health-related Quality of life of Participants Receiving Guselkumab Treatment as Assessed by Bowel Urgency | Up to Week 96 | Health-related Quality of life of participants receiving guselkumab treatment as assessed by bowel urgency will be reported. |
| Health-related Quality of Life of Participants Receiving Guselkumab Treatment as Assessed by PRO-2 Components | Up to Week 96 | Health-related Quality of life of participants receiving guselkumab treatment as assessed by PRO-2 components will be reported. |
| Functional Assessment Of Chronic Illness (FACIT) Fatigue (FACIT-F) Scale Score | Up to Week 96 | 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. |
| Number of CD Participants Achieving Endoscopic Response as Measured by Simple Endoscopy Score-CD (SES-CD) | Up to Week 96 | 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. |
| Number of Participants Achieving Endoscopic Remission in Participants with CD | Up to Week 96 | 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. |
| Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score | Up to Week 96 | 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. |
| Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score | Up to Week 96 | 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. |
| Number of Participants Achieving Histological Improvement in Participants with UC as Measured by Nancy Score | Up to Week 96 | 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). |
| Number of Participants Achieving Histological Remission in Participants with UC as Measured by Nancy Score | Up to Week 96 | 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). |
| Number of Participants Achieving Intestinal Utrasound (IUS) Response in Participants with CD as Measured by Bowel Wall Thickness (BWT) | At Weeks 24, 48, 72, 96 | 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. |
| Number of Participants Achieving IUS (Transmural) Remission in Participants with CD as Measured by BWT | At Weeks 24, 48, 72, 96 | 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 |
| Number of Participants Achieving Magnetic Resonance Enterography (MRE) Response in Participants with CD | Up to Week 96 | MRE response is defined as improvement of bowel wall thickness and contrast enhancement compared to baseline. |
| Number of Participants Achieving MRE Remission in Participants with CD | Up to Week 96 | MRE remission is defined as bowel wall thickness \<=3 mm without segmental mural hyperenhancement. |
| Change from Baseline in Satisfaction with Guselkumab Treatment as per Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score | 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. 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. |
| Change from Baseline in Number of UC/CD Emergency Room Visits | Baseline, Weeks 12, 48, 96 | Change in the number of emergency room visits for treatment of UC/CD will be reported. |
| Change from Baseline in Number of UC/CD Hospitalizations | Baseline, Weeks 12, 48, 96 | Change in the number of hospitalizations for treatment of UC/CD will be reported. |
| Change from Baseline in Number of UC/CD Surgeries | Baseline, Weeks 12, 48, 96 | Change in the number of surgeries for treatment of UC/CD will be reported. |
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed