An observational study in Colitis, Ulcerative and Crohn Disease, sponsored by Janssen Research & Development, LLC. Recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Observational
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.
127 studies on the registry are indexed under Colitis; 31 are open to participants now.
This study's planned enrollment of 100 is below the median of 123 across 27 observational studies indexed under Colitis.
Browse Colitis studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will include participants with confirmed diagnosis of moderate-to-severe crohn's disease (CD) or ulcerative colitis (UC) disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Up to Week 96
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).
Time frame: Weeks 0, 1, 2, 4, 8, and 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free remission for UC
Participants Achieving Corticosteroid-free remission for UC will be reported.
Time frame: Weeks 24, 48 and 96
Number of Participants Achieving Corticosteroid-free remission for CD
Participants Achieving Corticosteroid-free remission for CD will be reported.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 24, 48 and 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 Use
Number of participants using the previous inflammatory bowel disease (IBD) medication 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
Number of participants reporting the disease severity will be assessed.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis
Participants 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 of participants with Comorbid Diagnoses will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD
Number of participants with a 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 will be reported.
Time frame: 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.
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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0, 12, 48 and 96
Plan to share: Yes — 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
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jan 2029, 31 months after the start.
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