ColitisEAGLENCT07541261
A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia
An observational study of Colitis and Ulcerative, run by Janssen Research & Development, LLC at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative, Crohn Disease
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 May 2026to 29 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include participants with confirmed diagnosis of moderate-to-severe crohn's disease (CD) or ulcerative colitis (UC) disease.
Who may be able to join
- The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent
- The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
- The participant must sign a participation agreement/informed consent form (ICF) allowing source data verification
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Al Salama Hospital
Jeddah, 23611
About this study
Official title: A Multi-Center, Non-Interventional Study on Effectiveness and Treatment Persistence of Guselkumab in Patients With ULcerative Colitis and Crohn's DiseasE in Real-World Practice in Saudi Arabia
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.
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Medical subject headings
- Colitis, Ulcer, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD): Guselkumab | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 96
Secondary outcomes (36)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free remission for UC
Participants Achieving Corticosteroid-free remission for UC will be reported.
Measured: Weeks 24, 48 and 96
Number of Participants Achieving Corticosteroid-free remission for CD
Participants Achieving Corticosteroid-free remission for CD will be reported.
Measured: 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.
Measured: 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.
Measured: Weeks 24, 48 and 96
Characteristics of Participants Receiving Guselkumab Treatment: Age
Age of participants receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Sex
Sex of participants receiving guselkumab treatment will be reported.
Measured: 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.
Measured: 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.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Height
Height of participants receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Weight of participants receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity
Number of participants reporting the disease severity will be assessed.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis
Participants age at diagnosis will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Participants disease duration will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses
Number of participants with Comorbid Diagnoses will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD
Number of participants with a history of UC/CD will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0, 12, 48 and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start12 May 2026
- Primary completion2 Jan 2029 (estimated)
- Study completion29 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColitisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541261
- Sponsor's protocol ID
- CNTO1959IBD4009
- Acronym
- EAGLE
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Non-Interventional Study on Effectiveness and Treatment Persistence of Guselkumab in Patients With ULcerative Colitis and Crohn's DiseasE in Real-World Practice in Saudi Arabia
- ClinicalTrials.gov ID
- NCT07541261
- Acronym / sponsor ID
- EAGLE / CNTO1959IBD4009
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 May 2026 (actual)
- Primary completion
- 2 Jan 2029 (estimated)
- Study completion
- 29 Jan 2029 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD): Guselkumab | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include participants with confirmed diagnosis of moderate-to-severe crohn's disease (CD) or ulcerative colitis (UC) disease.
Key inclusion criteria (3 listed)
- The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent
- The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
- The participant must sign a participation agreement/informed consent form (ICF) allowing source data verification
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Guselkumab Discontinuation
Time frame: Up to Week 96
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.
36 secondary outcomes
Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components for Crohn's Disease (CD)
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)
Time frame: Weeks 0, 1, 2, 4, 8, and 12
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
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)
Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Clinical Response for UC as Measured by Partial Mayo Score (PMS)
Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free remission for UC
Time frame: Weeks 24, 48 and 96
Number of Participants Achieving Corticosteroid-free remission for CD
Time frame: Weeks 24, 48 and 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC
Time frame: Weeks 24, 48 and 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD
Time frame: Weeks 24, 48 and 96
Characteristics of Participants Receiving Guselkumab Treatment: Age
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Sex
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Height
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries
Time frame: At Baseline
Number of Participants with Adverse Events (AEs)
Time frame: Up to Week 96
Change in C-reactive protein (CRP) Levels
Time frame: Week 0, 12, 48 and 96
Change in Fecal Calprotectin (Fcal) Levels
Time frame: Week 0, 12, 48 and 96
Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment
Time frame: Baseline up to Week 96
Health-related Quality of Life As Assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score
Time frame: Week 0, 12, 48 and 96
Health-related Quality of life of Participants Receiving Guselkumab Treatment as Assessed by Bowel Urgency
Time frame: Week 0, 12, 48 and 96
Health-related Quality of Life of Participants Receiving Guselkumab Treatment as Assessed by PRO-2 Components
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
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)
Time frame: Week 0, 12, 48 and 96
Number of Participants Achieving Endoscopic Remission in Participants with CD
Time frame: Week 0, 12, 48 and 96
Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score
Time frame: Week 0, 12, 48 and 96
Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score
Time frame: Week 0, 12, 48 and 96
Change in Number of UC/CD Emergency Room Visits
Time frame: Week 0, 12, 48 and 96
Change in Number of UC/CD-Hospitalizations
Time frame: Week 0, 12, 48 and 96
Change in Number of UC/CD Surgeries
Time frame: Week 0, 12, 48 and 96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colitis and Ulcerative, run by Janssen Research & Development, LLC at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Guselkumab Discontinuation (time frame: Up to Week 96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.