An observational study in Inflammatory Bowel Disease, Colitis, Ulcerative and Crohn's Disease, sponsored by Janssen-Cilag Ltd.. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen-Cilag Ltd. (part of Johnson & Johnson) · Observational
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.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's planned enrollment of 220 is above the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Janssen-Cilag Ltd. is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
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 standard clinical practice and medical records will be collected.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 96
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.
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
Participants with early responses to guselkumab using PRO-2 components will be assessed and reported via patient diary card.
Time frame: 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.
Time frame: 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).
Time frame: Up to Week 96
Characteristics of Participants Receiving Guselkumab Treatment: Age
Characteristics of participants (age) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Sex
Characteristics of participants (sex) receiving guselkumab treatment will be reported.
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
Characteristics of participants (previous IBD medication use, smoking status and history, history of UC and history of CD) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Height
Characteristics of participants (height) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Characteristics of participants (weight) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity
Characteristics of participants (disease severity at index) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis
Characteristics of participants (age at diagnosis) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Characteristics of participants (disease duration) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses
Characteristics of participants (comorbid diagnoses) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries
Characteristics of participants (IBD-related surgeries) receiving guselkumab treatment will be reported.
Time frame: 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.
Time frame: Up to Week 96
Change in C-reactive protein (CRP) Levels
Change in CRP levels since guselkumab initiation will be reported.
Time frame: 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.
Time frame: At Week 0, 4, 12, 48 and 96
Change in Faecal Calprotectin (Fcal) Levels
Change in Fcal levels since guselkumab initiation will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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)
Endoscopic response is defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score \<4.
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
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.
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
Endoscopic Improvement is defined as a Mayo score \<=1.
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
Endoscopic normalization is defined as a Mayo score =0.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Weeks 12, 48 and 96
Plan to share: No
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