An observational study in Crohn Disease and Colitis, Ulcerative, sponsored by Janssen Cilag S.A.S.. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Janssen Cilag S.A.S. (part of Johnson & Johnson) · Observational
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Among 63 studies in Crohn Disease by Johnson & Johnson — 16 open to participants now, 23 under way, 10 of them phase 3. Crohn Disease · Johnson & Johnson.
Among the 63 studies in Crohn Disease by Johnson & Johnson, this one is the 16th largest by enrollment of the 22 observational ones that give a count, is one of 5 that started in 2018, is one of 22 observational ones, and was the 30th registered.
1,992 studies on the registry are indexed under Crohn Disease; 477 are open to participants now.
Browse Crohn Disease studies →16 of the 63 studies in Crohn Disease by Johnson & Johnson are open now, in 12 countries. Recruiting first, the newest first:
Janssen Research & Development, LLC · Sites in United States
Ages 18+ · Women only
Janssen-Cilag Pharma GmbH · Sites in Austria
Ages 18+
Janssen Research & Development, LLC · Sites in United States, Argentina, Australia and 27 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in Saudi Arabia
Ages 18+
Janssen Research & Development, LLC · Sites in United States, Austria, Belgium and 14 more countries
Ages 18+
By country, each count listing its studies:
Of the 353 Crohn Disease studies recruiting now, 154 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 95 take children under 18; 56 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.
63 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 2 · Phase 2 10 · Phase 3 26 · Phase 4 5
First in 1995; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 111 is below the median of 185 across 645 observational studies indexed under Crohn Disease.
Median enrollment 189 across the 40 interventional studies, 200 across the 22 observational. Of the 38 that completed or were terminated, 16 (42%) have results posted.
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This study is registered under Janssen Cilag S.A.S., one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Cilag S.A.S. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
6 of the studies in Crohn Disease by Johnson & Johnson that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT05092269Phase 3Janssen Research & Development, LLCA Long-term Extension Study of Ustekinumab in Pediatric Participants | 2027-09-29 |
| NCT05923073Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | 2027-10-27 |
| NCT07654751Janssen Research & Development, LLCA Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically | 2027-08-31 |
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Among the 63 studies in Crohn Disease by Johnson & Johnson, from their registry updates:
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The purpose of this study is to assess the effectiveness of ustekinumab on extra-intestinal manifestations (EIMs) and immune-mediated inflammatory diseases (IMIDs) associated with inflammatory bowel disease (IBD) (both Crohn's Disease [CD] and Ulcerative Colitis [UC]).
The study population will be participants with a confirmed diagnosis of moderate to severe Crohn's Disease (CD) or Ulcerative Colitis (UC) with at least one extra-intestinal manifestation (EIM) or immune-mediated inflammatory disease (IMID) of interest and for which a treatment with ustekinumab is indicated according to the clinical practice and Summary of Product Characteristics (SmPC).
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IBD (Crohn's Disease \[CD\] or Ulcerative Colitis \[UC\]) participants with suspected extra-intestinal manifestations (EIMs) and/or one or more immune-mediated inflammatory diseases (IMIDs) will be enrolled into the study to assess effectiveness of ustekinumab on EIMs and/or IMIDs associated with IBD (both CD and UC). Participants will receive ustekinumab at study entry (Week 0) as treatment for IBD according to standard clinical practice and will be followed up to 24 weeks (+/- 3 weeks). Only data available per clinical practice will be collected within this study.
Drug: Ustekinumab
No study treatment will be administered as a part of this study. Participants who are initiating the treatment with ustekinumab, will be observed according to standard clinical practice.
Percentage of Participants Achieving a Clinical Response (CR) on at Least one Extra-intestinal Manifestation/Immune-mediated Inflammatory Disease (EIM/IMID) Associated with Inflammatory Bowel Disease (IBD) at Week 24
CR will be determined based on the measures collected by the investigators which will be assessed by the specialists based on these parameters: 2 points reduction in physician global assessment (PGA) score or PGA 0 or 1 (0= clear to 5=very severe) achieved for cutaneous disease, or resolution of lesions for Erythema nodosum (dermatology); decrease of 50 percent (%) of ankylosing spondylitis disease activity index (BASDAI) (1=no problem to 10=worst problem) for axial spondyloarthritis (SpA); disease activity score (DAS)28 (derived from 4 items with score \<2.6 \[disease remission\] and \>5.1 \[severe disease activity\]) of moderate and good response achieved in peripheral SpA plus 2 points reduction in PGA score or PGA 0 or 1 achieved in case of associated psoriasis; resolution of dactylitis, decrease of 50% of Leeds enthesitis index \[LEI-6\] score which ranges from 0 \[pain/tenderness absent\] to1 \[pain/tenderness present\] for enthesitis, (rheumatology); resolution of uveitis (ophthalmology).
Time frame: Week 24
Percentage of Participants with Change from Baseline in Clinical Response for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
HBI is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well-being.
Time frame: Baseline, Week 16 and Week 24
Percentage of Participants Achieving Remission for CD as Measured by HBI
Percentage of participants achieving remission for CD will be measured using the HBI Score less than or equal to (\<= 4). HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well-being.
Time frame: Up to Week 24
Change from Baseline in Partial Mayo Score
Mayo scoring system is used for assessment of ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each ranging from 0 to 3. Partial Mayo score is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, and physician's global assessment) and ranges from 0 to 9 points. Higher score indicates severe disease. Change from baseline in the Partial Mayo Score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1 will be reported.
Time frame: Baseline, Week 16 and Week 24
Percentage of Participants Achieving Remission for UC as Measured by Partial Mayo Score (Score of <=2)
Percentage of participants achieving remission for UC will be measured using the Partial Mayo score Score less than or equal to \<=2). Partial Mayo score is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, and physician's global assessment) and ranges from 0 to 9 points. Higher score indicates severe disease.
Time frame: Up to Week 24
Change from Baseline in the Presence of Extra Intestinal Manifestations (EIMS) or Immune-Mediated Inflammatory Diseases (IMIDs)
Change from baseline in the presence of Extra Intestinal Manifestations (EIMs)/ Immune-Mediated Inflammatory Diseases (IMIDs) for its severity/activity will be determined.
Time frame: Baseline and Week 24
Work Productivity and Activity Impairment (WPAI) Questionnaire
The WPAI is a validated, self-administered questionnaire that assesses work and activity impairment during the past 7 days due to IBD. The WPAI score ranges from 0 to10. Score 0 means IBD had no effect on work and score 10 indicates because of IBD, could not work at all.
Time frame: Baseline, Weeks 16 and Week 24
Short Inflammatory Bowel Disease Questionnaire Score (Short IBDQ)
Short IBDQ is a health-related quality of life tool (HRQoL) to assess quality of life in adult participants with inflammatory bowel disease (IBD) having only 10 items with 4 domains: digestive symptoms (3 items), systemic symptoms (2 items), emotional disturbance (3 items), and social function (2 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=all of the time; 2=most of the time; 3=a good bit of the time; 4=some of the time; 5=a little bit of the time; 6=hardly any of the time; 7=none of the time). Total score is calculated by adding the scores from each domain; the total score ranges from 10 to 70, where minimum score =10 (poor HRQoL) and maximum score =70 (good HRQoL).
Time frame: Baseline, Weeks 16 and 24
Functional Assessment of Chronic Illness Therapy Scale (FACIT)
FACIT-F scale is a 13 item fatigue scale with a 7 day recall period. It measures the level of fatigue during the usual daily activities. The level of fatigue is measured on a 4 point Likert scale (0=very much fatigued to 4=not at all fatigued). Total FACIT score is the sum of 13 items, ranging from 0 (not at all) to 52 (very much). Higher scores represent better outcomes.
Time frame: Baseline, Weeks 16 and 24
Inflammatory Bowel Disease-Disability Index (IBD-DI)
The IBD-DI consists of 28 items that evaluate the 5 domains of overall health, body function, body structures, activity participation and environmental factors. Each item response is graded from 0 to 4 for each area evaluated (0 = very good; 1 = Good; 2 = medium; 3 = Bad; 4 = Very bad). The final composite score representative of the overall degree of disability ranging from -80 (maximum degree of disability) to 22 (no disability).
Time frame: Baseline, Weeks 16 and 24
Number of Participants with Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 37 weeks
Number of IBD Related Medical Visits
Number of IBD related medical visits as a part of medical resources utilization will be reported.
Time frame: Week 24
Number of Days of IBD Related Hospitalization with Surgery
Number of days of IBD related hospitalization with surgery (defined as number of days from the day of admission to discharge) as a part of medical resources utilization will be reported.
Time frame: Week 24
Number of Days of IBD Related Hospitalization Without Surgery
Number of days of IBD related hospitalization without surgery (defined as number of days from the day of admission to discharge) as a part of medical resources utilization will be reported.
Time frame: Week 24
Number of IBD Related Emergency Visits
Number of IBD related emergency visits as a part of medical resources utilization will be reported.
Time frame: Week 24
Ran from Sep 2018 to primary completion in Mar 2023, 53 months.
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 53 months is above that.
Counting every sponsor, half of 304 studies reached it within 41 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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