Colitis, Ulcerative, Crohn Disease
Conditions
Brief summary
The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) 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 Sciences Ireland UC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant 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 * Participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records * Participant must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
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 | Persistence with guselkumab treatment will be assessed through time to guselkumab discontinuation which is defined as the time at which the next infusion should have taken place for a participant after their last scheduled infusion. It will be used to measure the guselkumab persistence in participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency | At Weeks 0 (baseline), 1, 2, 4, 8, 12 | Number of participants with early responses to guselkumab measured using bowel urgency will be assessed via participant diaries. |
| Number of Participants with Early Responses to Guselkumab Measured Using Patient Reported Outcome (PRO-2) Components | At Weeks 0 (baseline), 1, 2, 4, 8, 12 | Number of participants with early responses to guselkumab will be assessed using PRO-2 components and reported via participant diaries. Measurements captured include stool frequency, rectal bleeding, and abdominal pain. |
| CD Phenotype According to Montreal Classification: Behavior | At Baseline | Behavior (B1, non-structuring, non-penetrating; B2, structuring; B3, penetrating; p, perianal disease modifier) in participants with CD will be assessed according to Montreal classification. |
| 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 based on appropriate medical judgment. An AE does not necessarily have a causal relationship with the treatment. |
| Number of Participants with C-Reactive Protein (CRP) Normalization | At Weeks 0 (baseline), 4, 12, 48 and 96 | CRP normalization is defined as less than or equal to (\<=) 5 microgram per liter (mg/L) since baseline (among participants with elevated CRP at baseline). C-reactive protein is a marker of inflammation that will be measured by physicians following routine clinical practice. |
| Change in CRP Levels | At Weeks 0 (baseline), 4, 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. |
| Number of Participants Achieving IUS (Transmural) Response in Participants with UC as Measured by BWT | At Weeks 0 (baseline), 24, 48, 72, 96 | IUS response is defined as reduction of BWT of \>=25% accompanied by a decrease of at least one grade in color doppler signal, and decrease in Milan Ultrasound Criteria (MUC) score \>= 2 points from baseline (Week 0). |
| Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) Score | At Weeks 0 (baseline), 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 reduction in HBI by greater than or equal to (\>=)3 points from baseline or achieving HBI less than or equal to (\<=) 4. |
| Number of Participants Achieving Clinical Response for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS) | At Weeks 0 (baseline), 12, 48 and 96 | PMS 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. Higher score indicates severe disease. Clinical response for UC is defined as the PMS score less than (\<) 4 or \>= 30 percent (%) reduction from baseline. |
| Number of Participants Achieving Clinical Remission for CD as Measured by HBI Score | At Weeks 0 (baseline), 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 remission for CD is defined as a HBI score \<= 4. |
| Number of Participants Achieving Clinical Remission for UC as Measured by PMS | At Weeks 0 (baseline), 12, 48 and 96 | PMS 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. Higher score indicates severe disease. Clinical remission for UC is defined as the PMS score \< 2 and a rectal bleeding subscore of 0. |
| Number of Participants Achieving Corticosteroid-Free Clinical Remission for CD | At Weeks 0 (baseline), 12, 48 and 96 | Corticosteroid-free clinical remission for CD is defined as no use of corticosteroids for at least 30 days and a HBI score \<= 4. |
| Number of Participants Achieving Corticosteroid-Free Clinical Remission for UC | At Weeks 48 and 96 | Corticosteroid-free clinical remission for UC is defined as no use of corticosteroids for at least 30 day, PMS score \< 2 and a rectal bleeding subscore of 0. |
| Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD | At Weeks 12, 48 and 96 | Corticosteroid-free PRO-2 remission for CD is defined as an AP score \<=1 and a mean SF score \<=3, and no worsening of AP or SF compared with baseline with no use of corticosteroids for at least 30 days. |
| Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC | At Weeks 12, 48 and 96 | Corticosteroid free PRO-2 remission for UC is defined as an SF subscore of 0 or 1, where the SF subscore has not increased from baseline, and a rectal bleeding subscore of 0 with no use of corticosteroids for at least 30 days. |
| Characteristics of Participants Receiving Guselkumab Treatment: Age | At Baseline | Characteristics of participants (age) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Sex | At Baseline | Characteristics of participants (sex) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Usage | At Baseline | Characteristics of participants (previous IBD medication use) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History | At Baseline | Characteristics of participants (smoking status and history) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Height | At Baseline | Characteristics of participants (height) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Weight | At Baseline | Characteristics of participants (weight) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity At Index | At Baseline | Characteristics of participants (disease severity at index) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis | At Baseline | Characteristics of participants (age at diagnosis) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration | At Baseline | Characteristics of participants (disease duration) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses | At Baseline | Characteristics of participants (comorbid diagnoses) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD | At Baseline | Characteristics of participants (history of UC/CD) receiving guselkumab treatment will be reported. |
| Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries | At Baseline | Characteristics of participants (Previous IBD-related surgeries) receiving guselkumab treatment will be reported. |
| UC Phenotype According to the Montreal Classification: Extent of Disease | At Baseline | Extent of disease (E1, ulcerative proctitis \[limited to rectum\]; E2, left-sided colitis \[up to splenic flexure\]; E3, extensive colitis \[beyond splenic flexure\]) in participants with UC will be assessed according to Montreal classification. |
| UC Phenotype According to Montreal Classification: Severity | At Baseline | Severity (S0, clinical remission; S1, mild; S2, moderate; S3, severe) in participants with UC will be assessed according to Montreal classification. |
| CD Phenotype According to Montreal Classification: Age at Diagnosis | At Baseline | Age at diagnosis (A1, \<17 years; A2, 17-40 years, A3, \>40 years) in participants with CD will be assessed according to Montreal classification. |
| CD Phenotype According to Montreal Classification: Location | At Baseline | Location (L1, ileal; L2, colonic; L3, ileocolonic; L4, isolated upper disease) in participants with CD will be assessed according to Montreal classification. |
| Number of Participants with Fecal Calprotectin (Fcal) Normalization | At Weeks 0 (baseline), 4, 12, 48 and 96 | Fcal normalization is defined as percentage of Fcal \<= 250 microgram per gram (mcg/g) since baseline (among participants with calprotectin elevation at baseline). Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice where higher values indicate greater intestinal inflammation. |
| Change in Fcal Levels | At Weeks 0 (baseline), 4, 12, 48 and 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 receiving concomitant IBD medications during guselkumab treatment will be reported. |
| Health-Related Quality of life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | At Weeks 0 (baseline), 12, 48, and 96 | The SIBDQ is a 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. |
| HR-QoL as Measured by Bowel Urgency | At Weeks 0 (baseline), 12, 24, 48, 72 and 96 | HRQoL as measured by bowel urgency will be reported. Bowel urgency from participants will be asked as yes or no. |
| HR-QoL of Participants with CD Receiving Guselkumab Treatment as Measured by PRO-2 Components | At Weeks 0 (baseline), 4, 12, 24, 48, 72 and 96 | The CD PRO-2 consists of 2 items: abdominal pain (AP) and stool frequency (SF). AP is a numeric variable with a score between 0-3 and is self-reported by the participant for the 3 days preceding assessment as 0 (no pain), 1 (mild), 2 (moderate) or 3 (severe pain). SF is also a numeric variable calculated the number of liquid stools a participant has experienced over the past 3 days. |
| HR-QoL of Participants with UC Receiving Guselkumab Treatment as Measured by PRO-2 Components | At Weeks 0 (baseline), 4, 8,12, 24, 48, 72, 96 | The UC PRO-2 is composed of rectal bleeding and stool frequency. Rectal bleeding is a numeric variable with a score between 0-3 and is self-reported by the participants for the 3 days preceding assessment as 0 (None), 1 (Streaks of blood with stool in less than half of the cases), 2 (Obvious blood with stools in most cases) or 3 (Blood alone passes). SF is also a numeric variable calculated the number of liquid stools a participant has experienced over the past 3 days. |
| HRQoL as Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Questionnaire | At Weeks 0 (baseline), 12, 48, and 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. |
| HRQoL as Measured by Inflammatory Bowel Disease Fatigue (IBD-F) Scale Score | At Weeks 0 (baseline), 12, 48, and 96 | The IBD-F is a self-assessment scale to be used to diagnose fatigue or to monitor fatigue level over time. The IBD-F scale consists of three sections: Section I - identifies the level and duration of fatigue (5 questions); Section II - assesses the impact of fatigue on daily activities (30 questions); and Section III - can identify causes and other factors related to fatigue (5 questions). Score ranges from 0 to 4 where 0 denotes no fatigue and 4 denotes extreme fatigue. |
| Number of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD) Total Score | Up to Week 96 | Endoscopic response 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. |
| Number of Participants Achieving Endoscopic Remission in Participants with CD as Measured by SES-CD Total Score | 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. |
| 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 | Up to Week 96 | Histological improvement defined as neutrophil infiltration in \<5% of crypts, no crypt destruction, no erosions and ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score \<=3.1. |
| Number of Participants Achieving Histological Remission in Participants with UC | Up to Week 96 | Histological remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, no erosions, ulcerations or granulation tissue according the Geboes grading system, that is, Geboes score \<=2B.0. |
| Number of Participants Achieving IUS (Transmural) Response in Participants with CD as Measured by Bowel Wall Thickness (BWT) | At Weeks 0 (baseline), 24, 48, 72, 96 | Intestinal Ultrasound (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 (Week 0). |
| Number of Participants Achieving IUS (Transmural) Remission in Participants with CD as Measured by BWT | At Weeks 0 (baseline), 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 (Week 0). |
| Number of Participants Achieving IUS (Transmural) Remission in Participants with UC as Measured by BWT | At Weeks 24, 48, 72, 96 | IUS remission is defined as normalization of BWT and all other IUS parameters or normalization of BWT with a color doppler signal (CDS) grade of 0 or 1; a MUC score of \<6.2 (corresponds to a Mayo endoscopic score \[MES\] of \<1, whereas a MUC score of \<4.3 points aligns with a MES of 0). |
| Change from Baseline in Satisfaction with Guselkumab Treatment as per Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score | At Weeks 0 (baseline), 12, 48, 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. Here, higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement. |
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Sciences Ireland UC Clinical Trial
Janssen Sciences Ireland UC
Outcome results
None listed