Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Disease
Conditions
Brief summary
The purpose of this study is to evaluate how long guselkumab remains 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-Cilag A.G., Switzerland
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 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 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 confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records * Must sign a participation agreement/Informed consent form (ICF) allowing 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 Persistence | Up to Week 96 | Persistence with guselkumab will be measured through time to discontinuation (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 with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components | Baseline (at Week 0), Weeks 1, 2, 4, 8 and 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. |
| Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency | Baseline (at Week 0), Weeks 1, 2, 4, 8 and 12 | Number of participants with early responses to guselkumab will be assessed using bowel urgency and reported via participant diaries. Bowel urgency from participants will be asked as yes or no. |
| 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 Clinical Remission for CD as Measured by 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 remission for CD is defined as the HBI score \<= 4. |
| Number of Participants Achieving Clinical Remission for UC as Measured by 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 remission for UC is defined as the PMS \< 2 and a rectal bleeding subscore of 0. |
| Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI | Weeks 12, 48 and 96 | Corticosteroid-free clinical response for CD is defined as a reduction in HBI by \>=3 points from baseline or achieving HBI \<=4 with no use of corticosteroids for at least 30 days. |
| Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS | Weeks 12, 48 and 96 | Corticosteroid-free clinical response for UC is defined as PMS \<4 or \>=30% reduction from baseline and no use of steroids for at least 30 days. |
| Number of Participants Achieving Corticosteroid-free Clinical Remission for CD as Measured by HBI | Weeks 12, 48 and 96 | Corticosteroid-free remission for CD is defined as no use of steroids for at least 30 days and a HBI score \<=4. |
| Number of Participants Achieving Corticosteroid-free Clinical Remission for UC as Measured by PMS | Weeks 12, 48 and 96 | Corticosteroid-free clinical remission for UC is defined as a PMS score of \<2, no use of corticosteroids for at least 30 days and a rectal bleeding subscore of 0. |
| Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD | Baseline (Week 0), Weeks 12, 48 and 96 | Corticosteroid-free PRO-2 remission in CD participants is defined as an abdominal pain (AP) score \<=1 and a mean stool frequency (SF) score \<=3 and no worsening of AP or SF compared with baseline and no use of steroids for at least 30 days. |
| Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC | Baseline (Week 0), Weeks 12, 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. |
| 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: 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 | Baseline (Week 0), Weeks 4, 8, 12, 48 and 96 | Characteristics of participants (weight) 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: Disease Severity | At Baseline | Characteristics of participants (disease severity at index) 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 Inflammatory Bowel Disease (IBD) Medication Use | At Baseline | Characteristics of participants (previous IBD medication use) 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. |
| 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. |
| Number of Participants with Drug-Related Adverse Events | 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 is considered drug-related if there is at least a reasonable possibility that the study drug contributed to the event. |
| Number of Participants with Serious Adverse Events (SAE) | 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 SAE is any event that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, or is otherwise medically significant. |
| Number of Participants with Drug-Related Serious Adverse Events | Up to Week 96 | An adverse event is any untoward medical occurrence in a participant administered a medicinal product based on appropriate medical judgment. SAE is any event that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, or is otherwise medically significant based on appropriate medical judgment. An SAE is considered drug-related if there is at least a reasonable possibility that the study drug contributed to the event. |
| Number of Participants with C-reactive protein (CRP) Normalization | Baseline (at Week 0), Weeks 4, 12, 48 and 96 | CRP normalization is defined as as \<= 5 milligrams/litre (mg/L) since baseline (among participants with elevated CRP at Baseline). |
| Change in CRP Levels | Weeks 4, 12, 48 and 96 | Change in CRP levels since guselkumab initiation will be reported. |
| Number of Participants with Fecal Calprotectin Normalization | Baseline (at Week 0), Weeks 4, 12, 48 and 96 | Number of participants with fecal calprotectin normalization will be reported. Normalization is defined as percentage of fecal calprotectin (fCAL) \<=250 micrograms/gram (mcg/g) since baseline (among participants with Calprotectin elevation at Baseline). |
| Change in Fecal Calprotectin Levels | Weeks 4, 12, 48 and 96 | Change in Fecal calprotectin levels since guselkumab initiation will be reported. |
| Change in Leukocytes Count | Baseline (at Week 0), Weeks 4, 12, 48 and 96 | Change in Leukocytes count will be reported. |
| Change in Hemoglobin Levels | Baseline (at Week 0), Weeks 4, 12, 48 and 96 | Change in hemoglobin levels to assess anaemia will be reported. |
| Change in Transferrin Saturation Levels | Baseline (at Week 0), Weeks 4, 12, 48 and 96 | Change in transferrin saturation Levels to assess anaemia will be reported. |
| Change in Ferritin Levels | Baseline (at Week 0), Weeks 4, 12, 48 and 96 | Change in Ferritin Levels to assess anaemia will be reported. |
| 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. |
| Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by PRO-2 Components for CD | Baseline (at Week 0), Weeks 24, 48, 72, and 96 | Change from baseline in HRQoL for CD will be measured by PRO-2 components. 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. |
| Change from Baseline in HRQoL as Measured by PRO-2 Components for UC | Baseline (at Week 0), Weeks 24, 48, 72, and 96 | Change from baseline in HRQoL for UC will be measured by PRO-2 components. 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. |
| Change from Baseline in HRQoL as Measured by Bowel Urgency | Baseline (at Week 0), Weeks 1, 2, 4, 8, 12, 24, 48, 72, and 96 | Change from baseline in HRQoL as measured by bowel urgency will be reported. Bowel urgency from participants will be asked as yes or no. |
| Changes from Baseline in HRQoL as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96 | SIBDQ is a HRQoL tool measuring physical, social, and emotional status in IBD participants. The SIBDQ offers a broader evaluation of IBD-specific QoL across ten dimensions, including digestive, physical, emotional, and social aspects. The SIBDQ consists of 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, irritability, impact on leisure, impact on intimacy). The total score ranges from 10 to 70, where high score indicates better QoL. |
| Changes from Baseline in HRQoL as Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Questionnnaire | Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96 | FACIT-F consists of 13 items to characterize fatigue symptoms and their impact on daily activities and function. It includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning (for example, sleeping and social activities) over the last 7 days. The total FACIT-F score ranges from 0 to 52, with a higher score indicating less fatigue. |
| Change from Baseline in HRQoL as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9) | Baseline (at Week 0), Weeks 12, 24, 48, 72 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. with higher score indicating higher treatment satisfaction. |
| Change from Baseline in HRQol as Measured by Work Productivity and Activity Questionnaire (WPAI) | Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96 | WPAI assesses impairment of work and regular activities due to overall health and symptoms. WPAI measures past-7-day work and activity that impact in Scores range from 0% (no impairment) to 100% (complete impairment); higher = worse. Absenteeism, presenteeism, and overall work impairment are for employed participant and activity impairment is for all participants. |
| Change from Baseline in HRQoL as Measured by PROMIS Sleep Disturbance Short Form 8b (PROMIS 8b) | Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96 | The PROMIS 8b is a questionnaire based on the PROMIS sleep disturbance and sleep-related Impairment item banks. It contains the 8 best-performing items of these banks belonging to categories relating to qualitative, quantitative, behavioral, and symptom based dimensions of sleep and was found to provide greater measurement precision compared with other assessment instruments. |
| Change from Baseline in HRQoL as Measured by Short-CONFIDE Survey for IBD (s-CS-IBD) | Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96 | s-CS-IBD is shortened version of the CONFIDE questionnaire (Short-CONFIDE Survey for IBD consisting of 5 selected questions to better understand how IBD impacts sexual activity and if guselkumab treatment can improve this situation. |
| Number of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD) | Baseline (at Week 0), Weeks 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 as Measured by SES-CD | Baseline (at Week 0), Weeks 48 and 96 | Endoscopic remission is defined as SES-CD total score \<= 4 with at least 2 points reduction from baseline and no sub-score \>1 in any individual component. |
| Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score | Baseline (at Week 0), Weeks 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 | Baseline (at Week 0), Weeks 12, 48 and 96 | Endoscopic normalization is defined as a Mayo score =0. |
| Number of Participants Achieving Histologic Improvement | At Weeks 0, 48 and 96 | Histologic improvement is 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 Histologic Remission | At Weeks 0, 48 and 96 | Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, no erosions, and ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score \<=2B.0. |
| Number of Participants with CD Achieving Intestinal Ultrasound (IUS) Response | Baseline (at Week 0), Weeks 24, 48, 72, and 96 | IUS Response is defined as reduction of bowel wall thickness (BWT) of \>= 25% or normalization (\<= 3 millimeter \[mm\]) of the most affected segment in participants with increased BWT (\>3 mm) at baseline. |
| Number of Participants with CD Achieving IUS Remission | Baseline (at Week 0), Weeks 24, 48, 72, and 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) in participants with increased BWT (\>3mm) at baseline. |
| Change from Baseline in Number of UC/CD Emergency Room Visits | Baseline (at Week 0), Weeks 12, 48 and 96 | Change from baseline 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 (at Week 0), Weeks 12, 48 and 96 | Change from baseline in the number of hospitalizations for treatment of UC/CD will be reported. |
| Change from Baseline in Number of UC/CD Surgeries | Baseline (at Week 0), Weeks 12, 48 and 96 | Change from baseline in the number of surgeries for treatment of UC/CD will be reported. |
Countries
Switzerland
Contacts
CONTACTStudy Contact
Outcome results
None listed