Inflammatory Bowel DiseaseGUSTO-UKNCT07242248
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
An observational study of Inflammatory Bowel Disease and Colitis, Ulcerative, run by Janssen-Cilag Ltd. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn's Disease
- How many people
- 220 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2025to 17 Mar 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
- 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 in line with the Trust's/ Health Board's treatment guidance. Enrolment must take place before or at the day of first administration (but after treatment decision by physician)
- Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records
- Must sign a informed consent form (ICF) allowing source data verification in accordance with local requirements
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
- Has a 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.
United Kingdom1 site, 1 recruiting
- Recruiting
London North West University Healthcare NHS Trust
Harrow, HA1 3UJ
About this study
Official title: Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK
The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.
- Medical subject headings
- Inflammatory Bowel Diseases, 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 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 standard clinical practice and medical records will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Clinical Remission for Crohn's Disease (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 remission for CD is defined as the HBI score less than or equal to (<=) 4.
Measured: Up to Week 96
Number of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
Mayo scoring system is used to assess disease severity and treatment effectiveness. Clinical remission for UC is defined as the PMS score <=2 and a rectal bleeding subscore of 0.
Measured: Up to Week 96
Number of Participants Achieving Clinical Response for CD as Measured by 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 by greater than or equal to (>=) 3.
Measured: Up to Week 96
Number of Participants Achieving Clinical Response for UC as Measured by PMS
Mayo scoring system is used to assess disease severity and treatment effectiveness. Clinical response for UC is defined as the PMS <4 or >=30 percent (%) reduction of baseline PMS.
Measured: Up to Week 96
Number of Participants Achieving Corticosteroid-free Remission for CD as Measured by HBI
Corticosteroid-free remission for CD is defined as no use of steroids for at least 30 days and HBI score <=4. HBI score is used to assess disease severity and treatment effectiveness.
Measured: Up to Week 96
Number of Participants Achieving Corticosteroid-free Remission for UC as Measured by PMS
Corticosteroid-free clinical remission for UC is defined as no use of steroids for at least 30 days and PMS <2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.
Measured: Up to Week 96
Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI
Corticosteroid-free clinical response for CD is defined as no use of steroids for at least 30 days and a reduction in HBI score by >=3 points from baseline or achieving HBI score <=4. HBI score is used to assess disease severity and treatment effectiveness.
Measured: Up to Week 96
Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS
Corticosteroid-free clinical response for UC is defined as no use of steroids for at least 30 days and PMS <4 or >=30% reduction from baseline. Mayo scoring system is used to assess disease severity and treatment effectiveness.
Measured: Up to Week 96
Number of Participants Achieving Patient-Reported Outcome (PRO)-2 Corticosteroid-Free Remission for CD as Measured by HBI
Participants with corticosteroid-free remission by PRO-2 will be assessed. 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 corticosteroids for at least 30 days will be defined as a PRO-2 corticosteroid-free remission.
Measured: Up to Week 96
Number of Participants Achieving PRO-2 Corticosteroid-Free Remission for UC as Measured by PMS
Participants with corticosteroid-free remission by PRO-2 will be assessed. An SF score of 0 or 1, where it has not increased from baseline, and a rectal bleeding score of 0 with no use of corticosteroids for at least 30 days will be defined as a corticosteroid-free PRO-2 remission.
Measured: Up to Week 96
Secondary outcomes (41)
Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for UC
Participants with early responses to guselkumab using PRO-2 components will be assessed and reported via patient diary card.
Measured: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for CD
Participants with early responses to guselkumab using PRO-2 components will be assessed and reported via patient diary card.
Measured: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
Participants with early responses to guselkumab using bowel urgency will be assessed and reported via patient diary card. Change in bowel urgency for participants will be asked, that is, how severe were the bowel urgency.
Measured: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12
Time to Guselkumab Persistence
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).
Measured: Up to Week 96
Characteristics of Participants Receiving Guselkumab Treatment: Age
Characteristics of participants (age) receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Sex
Characteristics of participants (sex) receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD Medication Use, Smoking Status and History, History of UC and History of CD
Characteristics of participants (previous IBD medication use, smoking status and history, history of UC and history of CD) receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Height
Characteristics of participants (height) receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Characteristics of participants (weight) receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity
Characteristics of participants (disease severity at index) receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis
Characteristics of participants (age at diagnosis) receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Characteristics of participants (disease duration) receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses
Characteristics of participants (comorbid diagnoses) receiving guselkumab treatment will be reported.
Measured: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries
Characteristics of participants (IBD-related surgeries) receiving guselkumab treatment will be reported.
Measured: At Baseline
Number of Participants with Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a patient 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 Week 96
Change in C-reactive protein (CRP) Levels
Change in CRP levels since guselkumab initiation will be reported.
Measured: Baseline up to Week 96
Number of Participants with CRP Normalization
Participants with CRP normalization (among participants with CRP elevated at baseline) since guselkumab initiation will be reported.
Measured: At Week 0, 4, 12, 48 and 96
Change in Faecal Calprotectin (Fcal) Levels
Change in Fcal levels since guselkumab initiation will be reported.
Measured: Baseline up to Week 96
Number of Participants with Fcal Normalization
Participants with Fcal normalization (among participants with faecal calprotectin [Fcal] elevated at baseline) since guselkumab initiation will be reported.
Measured: At Week 0, 4, 12, 48 and 96
Change in Albumin Levels
Change in albumin levels to assess anaemia and nutritional status will be reported.
Measured: At Week 0, 4, 12, 48 and 96
Change in Hemoglobin Levels
Change in hemoglobin levels to assess anaemia and nutritional status will be reported.
Measured: At Week 0, 4, 12, 48 and 96
Change in Platelets Levels
Change in platelets levels to assess anaemia and nutritional status will be reported.
Measured: At Week 0, 4, 12, 48 and 96
Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment
Number of participants receiving concomitant medications for UC and CD will be reported.
Measured: Baseline up to Week 96
Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score
Health related quality of life changes as measured by SIBDQ will be reported. SIBDQ is a 10-item instrument developed to assess the participants perception of their health status specifically related to IBD over the past two weeks. The SIBDQ evaluates the following dimensions: psychological well-being (feelings of emotional health and stability), physical well-being (the impact of disease symptoms on physical health), social function (the influence of the disease on social activities and interactions) and digestive function (the effect of gastrointestinal symptoms on daily life). The total score ranges from 10 (worst health) to 70 (best health).
Measured: Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by Bowel Urgency
Health related quality of life changes as measured by bowel urgency will be reported. Change in bowel urgency for participants will be asked, that is, how severe were the bowel urgency.
Measured: Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by PRO-2 Components for Participants with CD
PRO-2 components that is change in SF and AP will be reported. Change in SF for participants will be asked, that is, how many bowel movements they had in last 24 hours, how many of those were very soft or liquid, or how many has occurred during the night. Change in AP for participants will be asked, that is, how severe was the abdominal pain in the last 24 hours.
Measured: Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by PRO-2 Components for Participants with UC
PRO-2 components that is change in SF and rectal bleeding will be reported. Change in SF for participants will be asked, that is, how many bowel movements they had in last 24 hours, how many of those were very soft or liquid, or how many has occurred during the night. Change in rectal bleeding for participants will be asked, that is, how severe were the rectal bleedings in the last 24 hours.
Measured: Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by IBD-Control Questionnaire (ICHOM)
Health related quality of life changes as measured by ICHOM will be reported. ICHOM measures overall disease control from the participants perspective.
Measured: Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Fatigue Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Scale
FACIT-F scale is a 13-item instrument that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases. 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.
Measured: Baseline (Week 0), 12, 48, and 96
Number of Participants Achieving Endoscopic Response for 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: Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Remission for Participants with CD as Measured by SES-CD
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.
Measured: Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Improvement for Participants with UC as Measured by Mayo Score
Endoscopic Improvement is defined as a Mayo score <=1.
Measured: Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Normalization for Participants with UC as Measured by Mayo Score
Endoscopic normalization is defined as a Mayo score =0.
Measured: Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Histologic Improvement
Histologic improvement is defined as neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score <=3.1.
Measured: At Weeks 0, 48 and 96
Number of Participants Achieving Histologic Remission
Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score <=2B.0.
Measured: At Weeks 0, 48 and 96
Number of Participants with CD Achieving Intestinal Ultrasound (IUS) Response
IUS Response is defined as reduction of 25% in bowel wall thickness (BWT) or a reduction from baseline of BWT >2 millimeter (mm) or reduction from baseline BWT >1 mm plus a decrease from baseline in color doppler >1 point per baseline pathological segment.
Measured: Baseline (at Week 0), Weeks 24, 48, 72, and 96
Number of Participants with CD Achieving IUS Remission
IUS Remission is defined as BWT <3 mm for ileum and colon plus Color Doppler signal (CDS) 0 in all segments.
Measured: Baseline (at Week 0), Weeks 24, 48, 72, and 96
Change from Baseline in Satisfaction with Guselkumab Treatment Using Treatment Satisfaction Questionnaire for Medication (TSQM)
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.
Measured: Baseline (Week 0), Weeks 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: Baseline, Weeks 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: Baseline, Weeks 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: Baseline, Weeks 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 Nov 2025
- Study start17 Nov 2025
- Primary completion5 Mar 2029 (estimated)
- Study completion17 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Limited Clinical Trial, Study director, Janssen-Cilag Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242248
- Sponsor's protocol ID
- CNTO1959IBD4006
- Other IDs
- CNTO1959IBD4006
- Acronym
- GUSTO-UK
- Status last verified
- Nov 2026
- First submitted
- 17 Nov 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK
- ClinicalTrials.gov ID
- NCT07242248
- Acronym / sponsor ID
- GUSTO-UK / CNTO1959IBD4006
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 5 Mar 2029 (estimated)
- Study completion
- 17 Mar 2029 (estimated)
- First posted
- 21 Nov 2025 (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 the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of 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 |
|---|---|---|
| Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD) | – | –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 standard clinical practice and medical records will be collected. |
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)
- 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 in line with the Trust's/ Health Board's treatment guidance. Enrolment must take place before or at the day of first administration (but after treatment decision by physician)
- Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records
- Must sign a informed consent form (ICF) allowing source data verification in accordance with local requirements
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
- Has a 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
Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Time frame: Up to Week 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 less than or equal to (<=) 4.
Number of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
Time frame: Up to Week 96
Mayo scoring system is used to assess disease severity and treatment effectiveness. Clinical remission for UC is defined as the PMS score <=2 and a rectal bleeding subscore of 0.
Number of Participants Achieving Clinical Response for CD as Measured by HBI
Time frame: Up to Week 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 by greater than or equal to (>=) 3.
Number of Participants Achieving Clinical Response for UC as Measured by PMS
Time frame: Up to Week 96
Mayo scoring system is used to assess disease severity and treatment effectiveness. Clinical response for UC is defined as the PMS <4 or >=30 percent (%) reduction of baseline PMS.
Number of Participants Achieving Corticosteroid-free Remission for CD as Measured by HBI
Time frame: Up to Week 96
Corticosteroid-free remission for CD is defined as no use of steroids for at least 30 days and HBI score <=4. HBI score is used to assess disease severity and treatment effectiveness.
Number of Participants Achieving Corticosteroid-free Remission for UC as Measured by PMS
Time frame: Up to Week 96
Corticosteroid-free clinical remission for UC is defined as no use of steroids for at least 30 days and PMS <2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.
Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI
Time frame: Up to Week 96
Corticosteroid-free clinical response for CD is defined as no use of steroids for at least 30 days and a reduction in HBI score by >=3 points from baseline or achieving HBI score <=4. HBI score is used to assess disease severity and treatment effectiveness.
Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS
Time frame: Up to Week 96
Corticosteroid-free clinical response for UC is defined as no use of steroids for at least 30 days and PMS <4 or >=30% reduction from baseline. Mayo scoring system is used to assess disease severity and treatment effectiveness.
Number of Participants Achieving Patient-Reported Outcome (PRO)-2 Corticosteroid-Free Remission for CD as Measured by HBI
Time frame: Up to Week 96
Participants with corticosteroid-free remission by PRO-2 will be assessed. 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 corticosteroids for at least 30 days will be defined as a PRO-2 corticosteroid-free remission.
Number of Participants Achieving PRO-2 Corticosteroid-Free Remission for UC as Measured by PMS
Time frame: Up to Week 96
Participants with corticosteroid-free remission by PRO-2 will be assessed. An SF score of 0 or 1, where it has not increased from baseline, and a rectal bleeding score of 0 with no use of corticosteroids for at least 30 days will be defined as a corticosteroid-free PRO-2 remission.
41 secondary outcomes
Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for UC
Time frame: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for CD
Time frame: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
Time frame: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12
Time to Guselkumab Persistence
Time frame: Up to Week 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 IBD Medication Use, Smoking Status and History, History of UC and History of CD
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: 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: Baseline up to Week 96
Number of Participants with CRP Normalization
Time frame: At Week 0, 4, 12, 48 and 96
Change in Faecal Calprotectin (Fcal) Levels
Time frame: Baseline up to Week 96
Number of Participants with Fcal Normalization
Time frame: At Week 0, 4, 12, 48 and 96
Change in Albumin Levels
Time frame: At Week 0, 4, 12, 48 and 96
Change in Hemoglobin Levels
Time frame: At Week 0, 4, 12, 48 and 96
Change in Platelets Levels
Time frame: At Week 0, 4, 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 (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score
Time frame: Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by Bowel Urgency
Time frame: Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by PRO-2 Components for Participants with CD
Time frame: Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by PRO-2 Components for Participants with UC
Time frame: Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by IBD-Control Questionnaire (ICHOM)
Time frame: Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Fatigue Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Scale
Time frame: Baseline (Week 0), 12, 48, and 96
Number of Participants Achieving Endoscopic Response for Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD)
Time frame: Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Remission for Participants with CD as Measured by SES-CD
Time frame: Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Improvement for Participants with UC as Measured by Mayo Score
Time frame: Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Normalization for Participants with UC as Measured by Mayo Score
Time frame: Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Histologic Improvement
Time frame: At Weeks 0, 48 and 96
Number of Participants Achieving Histologic Remission
Time frame: At Weeks 0, 48 and 96
Number of Participants with CD Achieving Intestinal Ultrasound (IUS) Response
Time frame: Baseline (at Week 0), Weeks 24, 48, 72, and 96
Number of Participants with CD Achieving IUS Remission
Time frame: Baseline (at Week 0), Weeks 24, 48, 72, and 96
Change from Baseline in Satisfaction with Guselkumab Treatment Using Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Baseline (Week 0), Weeks 12, 48, and 96
Change in Number of UC/CD Emergency Room Visits
Time frame: Baseline, Weeks 12, 48 and 96
Change in Number of UC/CD-Hospitalizations
Time frame: Baseline, Weeks 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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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 Limited Clinical Trial study director
Janssen-Cilag Limited
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 Inflammatory Bowel Disease and Colitis, Ulcerative, run by Janssen-Cilag Ltd. at 1 site in United Kingdom.
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 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 United Kingdom. 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?
Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI) (time frame: Up to Week 96). The study lists 10 primary outcomes in all. 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.