An observational study in Crohn Disease and Colitis, Ulcerative, sponsored by Janssen Sciences Ireland UC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Sciences Ireland UC (part of Johnson & Johnson) · Observational
The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 35 is below the median of 185 across 645 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Janssen Sciences Ireland UC is the lead sponsor of 29 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or ulcerative colitis (UC) disease receiving guselkumab in routine clinical practice.
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 crohn's disease (CD) or ulcerative colitis (UC) treated with guselkumab in accordance with routine clinical practice as per the approved prescribing label will be enrolled. No drug will be provided as a part of this study. Only data available from clinical practice and medical records will be collected within this study.
Time to Guselkumab Discontinuation
Persistence with guselkumab treatment will be assessed through time to guselkumab discontinuation which is defined as the time at which the next infusion should have taken place for a participant after their last scheduled infusion. It will be used to measure the guselkumab persistence in participants.
Time frame: Up to Week 96
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
Number of participants with early responses to guselkumab measured using bowel urgency will be assessed via participant diaries.
Time frame: At Weeks 0 (baseline), 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using Patient Reported Outcome (PRO-2) Components
Number of participants with early responses to guselkumab will be assessed using PRO-2 components and reported via participant diaries. Measurements captured include stool frequency, rectal bleeding, and abdominal pain.
Time frame: At Weeks 0 (baseline), 1, 2, 4, 8, 12
Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) Score
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 reduction in HBI by greater than or equal to (\>=)3 points from baseline or achieving HBI less than or equal to (\<=) 4.
Time frame: At Weeks 0 (baseline), 12, 48 and 96
Number of Participants Achieving Clinical Response for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
PMS 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. Higher score indicates severe disease. Clinical response for UC is defined as the PMS score less than (\<) 4 or \>= 30 percent (%) reduction from baseline.
Time frame: At Weeks 0 (baseline), 12, 48 and 96
Number of Participants Achieving Clinical Remission for CD as Measured by HBI Score
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 a HBI score \<= 4.
Time frame: At Weeks 0 (baseline), 12, 48 and 96
Number of Participants Achieving Clinical Remission for UC as Measured by PMS
PMS 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. Higher score indicates severe disease. Clinical remission for UC is defined as the PMS score \< 2 and a rectal bleeding subscore of 0.
Time frame: At Weeks 0 (baseline), 12, 48 and 96
Number of Participants Achieving Corticosteroid-Free Clinical Remission for CD
Corticosteroid-free clinical remission for CD is defined as no use of corticosteroids for at least 30 days and a HBI score \<= 4.
Time frame: At Weeks 0 (baseline), 12, 48 and 96
Number of Participants Achieving Corticosteroid-Free Clinical Remission for UC
Corticosteroid-free clinical remission for UC is defined as no use of corticosteroids for at least 30 day, PMS score \< 2 and a rectal bleeding subscore of 0.
Time frame: At Weeks 48 and 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD
Corticosteroid-free PRO-2 remission for CD is defined as an AP score \<=1 and a mean SF score \<=3, and no worsening of AP or SF compared with baseline with no use of corticosteroids for at least 30 days.
Time frame: At Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC
Corticosteroid free PRO-2 remission for UC is defined as an SF subscore of 0 or 1, where the SF subscore has not increased from baseline, and a rectal bleeding subscore of 0 with no use of corticosteroids for at least 30 days.
Time frame: At Weeks 12, 48 and 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 Inflammatory Bowel Disease (IBD) Medication Usage
Characteristics of participants (previous IBD medication use) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History
Characteristics of participants (smoking status and history) 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 At Index
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: History of UC/CD
Characteristics of participants (history of UC/CD) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries
Characteristics of participants (Previous IBD-related surgeries) receiving guselkumab treatment will be reported.
Time frame: At Baseline
UC Phenotype According to the Montreal Classification: Extent of Disease
Extent of disease (E1, ulcerative proctitis \[limited to rectum\]; E2, left-sided colitis \[up to splenic flexure\]; E3, extensive colitis \[beyond splenic flexure\]) in participants with UC will be assessed according to Montreal classification.
Time frame: At Baseline
UC Phenotype According to Montreal Classification: Severity
Severity (S0, clinical remission; S1, mild; S2, moderate; S3, severe) in participants with UC will be assessed according to Montreal classification.
Time frame: At Baseline
CD Phenotype According to Montreal Classification: Age at Diagnosis
Age at diagnosis (A1, \<17 years; A2, 17-40 years, A3, \>40 years) in participants with CD will be assessed according to Montreal classification.
Time frame: At Baseline
CD Phenotype According to Montreal Classification: Location
Location (L1, ileal; L2, colonic; L3, ileocolonic; L4, isolated upper disease) in participants with CD will be assessed according to Montreal classification.
Time frame: At Baseline
CD Phenotype According to Montreal Classification: Behavior
Behavior (B1, non-structuring, non-penetrating; B2, structuring; B3, penetrating; p, perianal disease modifier) in participants with CD will be assessed according to Montreal classification.
Time frame: At Baseline
Number of Participants with Adverse Events (AE)
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.
Time frame: Up to Week 96
Number of Participants with C-Reactive Protein (CRP) Normalization
CRP normalization is defined as less than or equal to (\<=) 5 microgram per liter (mg/L) since baseline (among participants with elevated CRP at baseline). C-reactive protein is a marker of inflammation that will be measured by physicians following routine clinical practice.
Time frame: At Weeks 0 (baseline), 4, 12, 48 and 96
Change in CRP Levels
Change in CRP levels since guselkumab initiation will be reported. C-reactive protein is a marker of inflammation that will be measured by physicians following routine clinical practice.
Time frame: At Weeks 0 (baseline), 4, 12, 48 and 96
Number of Participants with Fecal Calprotectin (Fcal) Normalization
Fcal normalization is defined as percentage of Fcal \<= 250 microgram per gram (mcg/g) since baseline (among participants with calprotectin elevation at baseline). Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice where higher values indicate greater intestinal inflammation.
Time frame: At Weeks 0 (baseline), 4, 12, 48 and 96
Change in Fcal Levels
Change in Fcal levels since guselkumab initiation will be reported. Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice where higher values indicate greater intestinal inflammation.
Time frame: At Weeks 0 (baseline), 4, 12, 48 and 96
Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment
Number of participants receiving concomitant IBD medications during guselkumab treatment will be reported.
Time frame: Up to Week 96
Health-Related Quality of life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
The SIBDQ is a HRQoL tool measuring physical, social, and emotional status in IBD participants. The SIBDQ is a 10-item survey measuring HRQoL over the last 2 weeks (frequency of bowel movement, abdominal cramps, fatigue, lack of energy, worry of surgery, fear of no toilet, ability to relax, irritable, impact on leisure, impact on intimacy). The total score ranges from 10 to 70, where high score indicates better QoL.
Time frame: At Weeks 0 (baseline), 12, 48, and 96
HR-QoL as Measured by Bowel Urgency
HRQoL as measured by bowel urgency will be reported. Bowel urgency from participants will be asked as yes or no.
Time frame: At Weeks 0 (baseline), 12, 24, 48, 72 and 96
HR-QoL of Participants with CD Receiving Guselkumab Treatment as Measured by PRO-2 Components
The CD PRO-2 consists of 2 items: abdominal pain (AP) and stool frequency (SF). AP is a numeric variable with a score between 0-3 and is self-reported by the participant for the 3 days preceding assessment as 0 (no pain), 1 (mild), 2 (moderate) or 3 (severe pain). SF is also a numeric variable calculated the number of liquid stools a participant has experienced over the past 3 days.
Time frame: At Weeks 0 (baseline), 4, 12, 24, 48, 72 and 96
HR-QoL of Participants with UC Receiving Guselkumab Treatment as Measured by PRO-2 Components
The UC PRO-2 is composed of rectal bleeding and stool frequency. Rectal bleeding is a numeric variable with a score between 0-3 and is self-reported by the participants for the 3 days preceding assessment as 0 (None), 1 (Streaks of blood with stool in less than half of the cases), 2 (Obvious blood with stools in most cases) or 3 (Blood alone passes). SF is also a numeric variable calculated the number of liquid stools a participant has experienced over the past 3 days.
Time frame: At Weeks 0 (baseline), 4, 8,12, 24, 48, 72, 96
HRQoL as Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Questionnaire
The FACIT-F scale is a 13-item instrument designed to assess fatigue/tiredness and its impact on daily activities and functioning in chronic diseases. The instrument includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning over the last 7 days. Scores are numeric and range from 0 to 52 with higher scores indicating less fatigue.
Time frame: At Weeks 0 (baseline), 12, 48, and 96
HRQoL as Measured by Inflammatory Bowel Disease Fatigue (IBD-F) Scale Score
The IBD-F is a self-assessment scale to be used to diagnose fatigue or to monitor fatigue level over time. The IBD-F scale consists of three sections: Section I - identifies the level and duration of fatigue (5 questions); Section II - assesses the impact of fatigue on daily activities (30 questions); and Section III - can identify causes and other factors related to fatigue (5 questions). Score ranges from 0 to 4 where 0 denotes no fatigue and 4 denotes extreme fatigue.
Time frame: At Weeks 0 (baseline), 12, 48, and 96
Number of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD) Total Score
Endoscopic response defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score \<4. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Time frame: Up to Week 96
Number of Participants Achieving Endoscopic Remission in Participants with CD as Measured by SES-CD Total Score
Endoscopic remission is defined as SES-CD total score \<=4 with at least 2 points reduction from baseline and no subscore \>1 in any individual component. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Time frame: Up to Week 96
Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score
Endoscopic improvement is defined as Mayo score \<=1. The Mayo clinic score is a composite index with total score ranging from 0 to 12. Higher scores indicate worse disease activity.
Time frame: Up to Week 96
Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score
Endoscopic normalization is defined as Mayo score =0. The Mayo clinic score is a composite index with a total score ranging from 0 to 12. Higher scores indicate worse disease activity.
Time frame: Up to Week 96
Number of Participants Achieving Histological Improvement in Participants with UC
Histological improvement defined as neutrophil infiltration in \<5% of crypts, no crypt destruction, no erosions and ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score \<=3.1.
Time frame: Up to Week 96
Number of Participants Achieving Histological Remission in Participants with UC
Histological remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, no erosions, ulcerations or granulation tissue according the Geboes grading system, that is, Geboes score \<=2B.0.
Time frame: Up to Week 96
Number of Participants Achieving IUS (Transmural) Response in Participants with CD as Measured by Bowel Wall Thickness (BWT)
Intestinal Ultrasound (IUS) response is defined as reduction of BWT of \>=25% or normalization (\<=3 millimeters \[mm\]) of the most affected segment at Weeks 24, 48, 72, 96 in participants with increased BWT (\>3 mm) at baseline (Week 0).
Time frame: At Weeks 0 (baseline), 24, 48, 72, 96
Number of Participants Achieving IUS (Transmural) Remission in Participants with CD as Measured by BWT
IUS remission is defined as normalization of BWT (\<=3 mm) and vascularity (no signal or short signal in color doppler of the most affected segment) at Weeks 24, 48, 72, 96, in participants with increased BWT (\> 3 mm) at baseline (Week 0).
Time frame: At Weeks 0 (baseline), 24, 48, 72, 96
Number of Participants Achieving IUS (Transmural) Response in Participants with UC as Measured by BWT
IUS response is defined as reduction of BWT of \>=25% accompanied by a decrease of at least one grade in color doppler signal, and decrease in Milan Ultrasound Criteria (MUC) score \>= 2 points from baseline (Week 0).
Time frame: At Weeks 0 (baseline), 24, 48, 72, 96
Number of Participants Achieving IUS (Transmural) Remission in Participants with UC as Measured by BWT
IUS remission is defined as normalization of BWT and all other IUS parameters or normalization of BWT with a color doppler signal (CDS) grade of 0 or 1; a MUC score of \<6.2 (corresponds to a Mayo endoscopic score \[MES\] of \<1, whereas a MUC score of \<4.3 points aligns with a MES of 0).
Time frame: At Weeks 24, 48, 72, 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. Here, higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.
Time frame: At Weeks 0 (baseline), 12, 48, 96
No study locations are listed for this record.
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2029, 32 months later.
Of 73 industry-sponsored observational studies under Crohn Disease, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 60. This study's planned 32 months is below that.
Counting every sponsor, half of 304 studies reached it within 42 months; a quarter within 29 and three quarters within 88.
Start moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Nov 3, 2026.
Completion moved twice since we started tracking on Sep 25, 2026: Sep 2029 → Nov 2029, last on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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