Colitis, UlcerativeGALILEONCT07848737
A Real-World Study of Guselkumab Persistence and Effectiveness in Participants With Crohn's Disease or Ulcerative Colitis
An observational study of Colitis, Ulcerative and Crohn Disease, run by Janssen-Cilag, S.A. at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system). 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
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2026to 30 Oct 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
- 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. Decision to prescribe must solely be made by the treating physician. Participant must have been at least 8 weeks under guselkumab treatment before being included in the study, regardless if they are still on guselkumab treatment or not
- Participant must have a confirmed diagnosis of moderate-to-severe or Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records: Harvey-Bradshaw Index (HBI) greater than (>)4 for CD and Partial Mayo Score (pMS)>2 for UC
- Participant [and/or their legally-acceptable representative where applicable] must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements
Who cannot join
- Contraindicated to guselkumab per the label
- It 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 the ICF
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Guselkumab: A Real Life Non-Interventional, Persistence and Effectiveness Study in Patients With Crohn's Disease or Ulcerative Colitis
The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Medical subject headings
- Colitis, Ulcerative, 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 |
|---|---|---|
| Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD) | Participants with confirmed diagnosis of moderate-to-severe UC or CD receiving guselkumab according to clinical practice will be enrolled. Only data available within clinical routine as standard of care will be documented for this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of Treatment with Guselkumab
Persistence of treatment with guselkumab will be measured through time to guselkumab discontinuation defined as the time at which the next infusion should have taken place for a participant after their last scheduled infusion.
Measured: Up to 96 weeks
Secondary outcomes (25)
Number of Participants Achieving Clinical Response for Crohn's disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Participants reporting effectiveness with treatment of guselkumab will be measured through the HBI for CD. 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. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain (AP), number of liquid stools per day, abdominal mass and complications.
Measured: Up to 96 weeks
Number of Participants Achieving Clinical Response for CD as Measured by Patient Reported Outcome (PRO-2)
Number of participants with clinical response to guselkumab will be assessed using PRO-2, including stool frequency and abdominal pain in CD participants through the patient's electronic (e)-diary.
Measured: Up to 96 weeks
Number of Participants Achieving Clinical Response for Ulcerative colitis (UC) as Measured by Partial Mayo Score (PMS)
Participants reporting effectiveness with treatment of guselkumab will be measured through the PMS for UC. Clinical response for UC is defined as the PMS score < 4 or >= 30 percent (%) reduction from baseline. PMS comprises 3 categories: rectal bleeding, stool frequency, and physician assessment.
Measured: Up to 96 weeks
Number of Participants Achieving Clinical Response for UC as Measured by PRO-2
Number of participants achieving clinical response to guselkumab will be assessed using PRO-2, including stool frequency and rectal bleeding in UC participants through the patient's e-diary.
Measured: Up to 96 weeks
Characteristics of Participants Receiving Guselkumab Treatment: Age
Age of participants receiving guselkumab treatment will be reported.
Measured: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Sex
Sex of participants receiving guselkumab treatment will be reported.
Measured: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use
Participants with previous IBD medication use will be reported.
Measured: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History
Smoking status and history of participants receiving guselkumab treatment will be reported.
Measured: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Height
Height of participants receiving guselkumab treatment will be reported.
Measured: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Weight of participants receiving guselkumab treatment will be reported.
Measured: At Weeks 0, 4, 12, 48 and 96
Characteristics of Participants Receiving Guselkumab Treatment: Disease Status
Disease status of participants receiving guselkumab treatment will be reported.
Measured: Up to 96 weeks
Characteristics of Participants Receiving Guselkumab Treatment: Severity at Index
Disease severity of participants will be reported.
Measured: Up To 96 weeks
Characteristics of Participants Receiving Guselkumab Treatment: Age At Diagnosis
Age at diagnosis of participants receiving guselkumab treatment will be reported.
Measured: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Participants disease duration at study initiation will be reported.
Measured: At Week 0
Number of Participants with Comorbid Diagnoses
Participants with comorbid diagnoses will be reported.
Measured: Up to 96 weeks
Number of Participants with History of UC/CD Previous IBD Related Therapy Use and Surgeries
Participants with history of UC/CD and previous IBD-related therapy use and surgeries will be reported.
Measured: At Week 0
Number of Participants Receiving Concomitant IBD Medications
Participants receiving concomitant IBD medications for UC and CD will be reported.
Measured: Up to 96 weeks
Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score
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: Baseline (Week 0) up to 96 weeks
Change from Baseline in Satisfaction with Guselkumab Treatment Using Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scale Score
The TSQM-9 is an abbreviated version of the 14-item TSQM, and is a reliable and valid measure to assess treatment satisfaction in naturalistic study designs, in which there is potential that the administration of the side effects domain of the TSQM would interfere with routine clinical care. 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.
Measured: Baseline (Week 0) up to 96 weeks
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: Baseline (Week 0) up to 96 weeks
Change in Number of UC/CD-Hospitalizations
Change in the number of hospitalizations for treatment of UC/CD will be reported.
Measured: Baseline (Week 0) up to 96 weeks
Change in Number of UC/CD Surgeries
Change in the number of surgeries for treatment of UC/CD will be reported.
Measured: Baseline (Week 0) up to 96 weeks
Change in C-Reactive Protein (CRP) Levels
Change in CRP levels since guselkumab initiation will be reported. CRP is a marker of inflammation that will be measured by physicians following routine clinical practice.
Measured: At Weeks 0, 4, 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: At Weeks 0, 4, 12, 48 and 96
Number of Participants with Adverse events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a medicinal product. 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 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.A. Clinical Trial, Study director, Janssen-Cilag, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848737
- Sponsor's protocol ID
- CNTO1959IBD4010
- Acronym
- GALILEO
- Status last verified
- Nov 2026
- First submitted
- 24 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guselkumab: A Real Life Non-Interventional, Persistence and Effectiveness Study in Patients With Crohn's Disease or Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07848737
- Acronym / sponsor ID
- GALILEO / CNTO1959IBD4010
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 30 Sep 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 purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD) | – | –Participants with confirmed diagnosis of moderate-to-severe UC or CD receiving guselkumab according to clinical practice will be enrolled. Only data available within clinical routine as standard of care will be documented for 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)
- 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. Decision to prescribe must solely be made by the treating physician. Participant must have been at least 8 weeks under guselkumab treatment before being included in the study, regardless if they are still on guselkumab treatment or not
- Participant must have a confirmed diagnosis of moderate-to-severe or Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records: Harvey-Bradshaw Index (HBI) greater than (>)4 for CD and Partial Mayo Score (pMS)>2 for UC
- Participant [and/or their legally-acceptable representative where applicable] must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements
Key exclusion criteria (5 listed)
- Contraindicated to guselkumab per the label
- It 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 the ICF
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
Persistence of Treatment with Guselkumab
Time frame: Up to 96 weeks
Persistence of treatment with guselkumab will be measured through time to guselkumab discontinuation defined as the time at which the next infusion should have taken place for a participant after their last scheduled infusion.
25 secondary outcomes
Number of Participants Achieving Clinical Response for Crohn's disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Time frame: Up to 96 weeks
Number of Participants Achieving Clinical Response for CD as Measured by Patient Reported Outcome (PRO-2)
Time frame: Up to 96 weeks
Number of Participants Achieving Clinical Response for Ulcerative colitis (UC) as Measured by Partial Mayo Score (PMS)
Time frame: Up to 96 weeks
Number of Participants Achieving Clinical Response for UC as Measured by PRO-2
Time frame: Up to 96 weeks
Characteristics of Participants Receiving Guselkumab Treatment: Age
Time frame: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Sex
Time frame: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use
Time frame: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History
Time frame: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Height
Time frame: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Time frame: At Weeks 0, 4, 12, 48 and 96
Characteristics of Participants Receiving Guselkumab Treatment: Disease Status
Time frame: Up to 96 weeks
Characteristics of Participants Receiving Guselkumab Treatment: Severity at Index
Time frame: Up To 96 weeks
Characteristics of Participants Receiving Guselkumab Treatment: Age At Diagnosis
Time frame: At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Time frame: At Week 0
Number of Participants with Comorbid Diagnoses
Time frame: Up to 96 weeks
Number of Participants with History of UC/CD Previous IBD Related Therapy Use and Surgeries
Time frame: At Week 0
Number of Participants Receiving Concomitant IBD Medications
Time frame: Up to 96 weeks
Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score
Time frame: Baseline (Week 0) up to 96 weeks
Change from Baseline in Satisfaction with Guselkumab Treatment Using Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scale Score
Time frame: Baseline (Week 0) up to 96 weeks
Change in Number of UC/CD Emergency Room Visits
Time frame: Baseline (Week 0) up to 96 weeks
Change in Number of UC/CD-Hospitalizations
Time frame: Baseline (Week 0) up to 96 weeks
Change in Number of UC/CD Surgeries
Time frame: Baseline (Week 0) up to 96 weeks
Change in C-Reactive Protein (CRP) Levels
Time frame: At Weeks 0, 4, 12, 48 and 96
Change in Fecal Calprotectin (Fcal) Levels
Time frame: At Weeks 0, 4, 12, 48 and 96
Number of Participants with Adverse events (AEs)
Time frame: Up to 96 weeks
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.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.
Janssen-Cilag S.A. Clinical Trial study director
Janssen-Cilag, S.A.
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, Ulcerative and Crohn Disease, run by Janssen-Cilag, S.A. at 1 site in Spain.
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: opening soon, as of the sponsor's last update on 3 Nov 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 Spain. 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?
Persistence of Treatment with Guselkumab (time frame: Up to 96 weeks). 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 3 Nov 2026.