An observational study in Inflammatory Bowel Diseases, sponsored by Janssen Research & Development, LLC. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Observational
Among 143 studies in Inflammatory Bowel Diseases with a site in France — 32 open to participants now, 43 under way, 7 of them phase 3. Inflammatory Bowel Diseases · France.
Among the 143 studies in Inflammatory Bowel Diseases with a site in France, this one is the 20th largest by planned enrollment of the 59 observational ones that give a count, is one of 7 that started in 2026, is one of 59 observational ones, reaches primary completion later than 38 of the 42 other live ones, and was the 142nd registered.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
Browse Inflammatory Bowel Diseases studies →32 of the 143 studies in Inflammatory Bowel Diseases with a site in France are open now. Recruiting first, the newest first:
Palisade Bio · Sites in France, United States, Canada and 9 more countries
Fondation Lenval · Sites in France
Raincy Montfermeil Hospital Group · Sites in France
Assistance Publique Hopitaux De Marseille · Sites in France
Spyre Therapeutics, Inc. · Sites in France, United States, Argentina and 32 more countries
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 278 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 118 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
143 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 22 · Phase 3 27 · Phase 4 2
First in 1990; this study’s year is marked. 7 started in 2026.
This study's planned enrollment of 400 is above the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.
Median enrollment 124 across the 84 interventional studies, 220 across the 59 observational. Of the 94 that completed or were terminated, 25 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
47 of 143 have an industry lead sponsor. The 10 most frequent:
Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Janssen Research & Development, LLC has 6 studies filed under Inflammatory Bowel Diseases — fewer than ten, so there is no comparison to draw.
11 of the studies in Inflammatory Bowel Diseases with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04997733Phase 3Assistance Publique - Hôpitaux de ParisFecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal | 2027-05-22 |
| NCT05923073Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | 2027-10-27 |
| NCT06261320Polyclinique de l'EuropeMesotherapy Treatment of Irritable Bowel Syndrome | 2026-12-31 |
| NCT07383844Fondation LenvalAnalysis of Barriers and Facilitators to Adapted Physical Activity for Pediatric Patients With Chronic Inflammatory Bowel Diseases | 2027-01-31 |
| NCT06805890Assistance Publique Hopitaux De MarseilleStudy of Tissue Repair in Inflammatory Bowel Disease Exploiting Organoid Technology | 2027-03-24 |
Among the 143 studies in Inflammatory Bowel Diseases with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.
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.
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.
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) will be enrolled according to the approved local prescribing label and treated with guselkumab according to the local clinical practice. No drug will be provided as part of this study. Only data available from clinical practice will be collected within this study.
Persistence with Guselkumab Treatment
Time to guselkumab discontinuation will be used to measure the guselkumab persistence in participants and is defined as the time from the first administration of guselkumab to its discontinuation date (defined as the date that the last dose of treatment was administered plus 1 dosing interval).
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 via bowel urgency will be assessed via participant diaries.
Time frame: At Weeks 0, 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using Simplified Patient-Reported Outcome (2-item) (PRO-2) Components in Participants with CD
Number of participants with early responses to guselkumab will be assessed via participant diaries. Measurements captured for CD include stool frequency and abdominal pain (AP).
Time frame: At Weeks 0, 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using Simplified Patient-Reported Outcome (2-item) (PRO-2) Components in Participants with UC
Number of participants with early responses to guselkumab will be assessed via participant diaries. Measurements captured for UC include rectal bleeding and stool frequency (SF).
Time frame: At Weeks 0, 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. Efficacy will be evaluated by line of treatment and subpopulation.
Time frame: Up to Week 96
Number of Participants Achieving Clinical Remission for CD as Measured by HBI Score
Clinical remission for CD is defined as a HBI score of \<= 4. Efficacy will be evaluated by line of treatment and subpopulation.
Time frame: Up to Week 96
Number of Participants Achieving Corticosteroid-Free Clinical Response for CD as Measured by HBI Score
Corticosteroid-free clinical response for CD is defined as the reduction in HBI \>=3 points from baseline or achieving HBI \<=4 with no use of corticosteroids for at least 30 days. Efficacy will be evaluated by line of treatment and subpopulation.
Time frame: Up to Week 96
Number of Participants Achieving Corticosteroid-Free Clinical Remission for CD
Corticosteroid-free clinical remission will be defined as a HBI score of \<= 4 and no use of corticosteroids for at least 30 days in participants with CD. Efficacy will be evaluated by line of treatment and subpopulation.
Time frame: Up to Week 96
Number of Participants Achieving Clinical Response for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
Mayo scoring system is used to assess disease severity and treatment effectiveness. The PMS comprises 3 categories: rectal bleeding, SF, and physician assessment. These are rated from 0-3 and are summed to give a total score that ranges from 0-12. Clinical response for UC is defined as the PMS score less than (\<) 4 or \>= 30 percent (%) reduction from baseline. Efficacy will be evaluated by line of treatment and subpopulation.
Time frame: Up to Week 96
Number of Participants Achieving Clinical Remission for UC as Measured by PMS
Clinical remission for UC is defined as the PMS score \< 2 and a rectal bleeding subscore of 0. Efficacy will be evaluated by line of treatment and subpopulation.
Time frame: Up to Week 96
Number of Participants Achieving Corticosteroid-Free Clinical Response for UC as Measured by PMS
Corticosteroid free clinical response is defined as a PMS score of \<4 or \>=30% reduction from baseline and no use of corticosteroids for at least 30 days. Efficacy will be evaluated by line of treatment and subpopulation.
Time frame: Up to Week 96
Number of Participants Achieving Corticosteroid-Free Clinical Remission for UC
Corticosteroid-free clinical remission will be defined as a PMS score of less than (\<)2, no use of corticosteroids for at least 30 days and a rectal bleeding subscore of 0 in participants with UC. Efficacy will be evaluated by line of treatment and subpopulation.
Time frame: Up to Week 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD
The CD PRO-2 consists of 2 items: abdominal pain and stool frequency. An AP score \<=1 and a mean SF score \<=3 and no worsening of AP or SF compared with baseline and no use of corticosteroids for at least 30 days in CD participants will be defined as a corticosteroid-free PRO-2 remission. Efficacy will be evaluated by line of treatment and subpopulation.
Time frame: Up to Week 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC
The UC PRO-2 is composed of rectal bleeding and stool frequency. An SF subscore of 0 or 1, where it has not increased from baseline, and a PMS rectal bleeding subscore of 0 with no use of corticosteroids for at least 30 days in UC participants will be defined as a corticosteroid-free PRO-2 remission. Efficacy will be evaluated by line of treatment and subpopulation.
Time frame: Up to Week 96
Characteristics of Participants Receiving Guselkumab Treatment: Age
Age of participants receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Sex
Sex of participants receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Usage
The number and type of previous inflammatory bowel disease (IBD) medication used by participant will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History
Number of participants with current and former smoking status receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Height
Height of participants receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Weight of participants receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity At Index
Disease severity per participant at baseline will be assessed.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis
Participant's age at diagnosis will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Participants disease duration will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses
Number and nature of comorbidities per participant will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD
Number of participants with history of UC/CD will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries
Number of participants who have undergone previous IBD-related surgeries and the nature of surgeries will be reported.
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. An adverse event 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. C-reactive protein is a marker of inflammation that will be measured by physicians following routine clinical practice.
Time frame: Up to Week 96
Change in Fecal Calprotectin (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: Up to Week 96
Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment
Number of participants with concomitant IBD medications and the type of concomitant medications given during guselkumab treatment will be reported.
Time frame: Up to Week 96
Health-related Quality of Life As Assessed by Short IBD Questionnaire (SIBDQ) Total Score
The SIBDQ is a health-related quality of life (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: Up to Week 96
Health-related Quality of life of Participants Receiving Guselkumab Treatment as Assessed by Bowel Urgency
Health-related Quality of life of participants receiving guselkumab treatment as assessed by bowel urgency will be reported.
Time frame: Up to Week 96
Health-related Quality of Life of Participants Receiving Guselkumab Treatment as Assessed by PRO-2 Components
Health-related Quality of life of participants receiving guselkumab treatment as assessed by PRO-2 components will be reported.
Time frame: Up to Week 96
Functional Assessment Of Chronic Illness (FACIT) Fatigue (FACIT-F) Scale Score
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: Up to Week 96
Number of CD Participants Achieving Endoscopic Response 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. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease. If SES-CD is not available, response is defined as a reduction in ulcer size, number or extend on endoscopy compared to baseline.
Time frame: Up to Week 96
Number of Participants Achieving Endoscopic Remission in Participants with CD
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. If SES-CD is not available, response is defined as an absence of mucosal ulcers as seen on endoscopy.
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 as Measured by Nancy Score
Histological improvement defined by a reduction in the Nancy score by at least one point compared to baseline will be reported. The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease).
Time frame: Up to Week 96
Number of Participants Achieving Histological Remission in Participants with UC as Measured by Nancy Score
Histological remission defined by a Nancy score of 0 or 1 will be reported. The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease).
Time frame: Up to Week 96
Number of Participants Achieving Intestinal Utrasound (IUS) Response in Participants with CD as Measured by Bowel Wall Thickness (BWT)
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.
Time frame: At Weeks 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
Time frame: At Weeks 24, 48, 72, 96
Number of Participants Achieving Magnetic Resonance Enterography (MRE) Response in Participants with CD
MRE response is defined as improvement of bowel wall thickness and contrast enhancement compared to baseline.
Time frame: Up to Week 96
Number of Participants Achieving MRE Remission in Participants with CD
MRE remission is defined as bowel wall thickness \<=3 mm without segmental mural hyperenhancement.
Time frame: Up to Week 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. t 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: Baseline, Weeks 12, 48, and 96
Change from Baseline 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, 96
Change from Baseline 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, 96
Change from Baseline 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, 96
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 ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jan 2030, 39 months after the start.
Of 37 industry-sponsored observational studies under Inflammatory Bowel Diseases, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 44. This study's planned 39 months is above that.
Counting every sponsor, half of 280 studies reached it within 36 months; a quarter within 20 and three quarters within 122.
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 ↗
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