Crohn DiseaseTENORNCT03606499
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
An observational study of Crohn Disease and Colitis, Ulcerative, run by Janssen Cilag S.A.S. at 1 site in France.
Trial summary
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]). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Colitis, Ulcerative
- What is being tested?
- Ustekinumab
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2018to 17 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 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).
Who may be able to join
- With a confirmed diagnosis of CD or UC
- With at least one EIM of interest (cutaneous: pyoderma gangrenosum; erythema nodosum, articular: axial spondyloarthritis and peripheral spondyloarthritis with and without psoriasis, dactylitis, enthesitis; ocular: uveitis) and/or at least one IMIDs of interest (cutaneous: psoriasis, atopic dermatitis, hidradenitis suppurativa), suspected or confirmed, that is active at the time of screening
- Starting ustekinumab as a biologic therapy for CD or UC treatment independently of their enrollment into the study
- Using ustekinumab according to the SmPC
- Only for participants with CD: has had an inadequate response with or lost response to or be intolerant to conventional therapy including azathioprine, 6-mercaptopurine or corticosteroids or; at least one tumor necrosis factor (TNF) blocker (adalimumab, infliximab). Only for participants with UC: Have had an inadequate response with, lost response to, or were intolerant to either conventional including azathioprine, 6-mercaptopurine or corticosteroids or a biologic
Who cannot join
- Participants suffering from a psoriasis induced by a biological therapy at inclusion (including TNF blocker) or participant presenting an active psoriasis that was diagnosed before the time of inflammatory bowel disease (IBD) diagnosis
- Participants currently enrolled in an investigational study (or have been in the past 2 months) or are unwilling or not able to understand or provide their consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ustekinumab in Patients Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases in a Real-world Setting
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]).
- Conditions
- Crohn Disease, Colitis, Ulcerative
- Being tested
- Ustekinumab
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease (IBD) Participants with EIMs and/or IMIDs | 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. Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 24
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24
Number of IBD Related Emergency Visits
Number of IBD related emergency visits as a part of medical resources utilization will be reported.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start26 Sep 2018
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Cilag S.A.S., France Clinical Trial, Study director, Janssen Cilag S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606499
- Sponsor's protocol ID
- CR108498
- Other IDs
- CNTO1275CRD4012
- Acronym
- TENOR
- Status last verified
- Apr 2025
- First submitted
- 20 Jul 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ustekinumab in Patients Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases in a Real-world Setting
- ClinicalTrials.gov ID
- NCT03606499
- Acronym / sponsor ID
- TENOR / CR108498
- Conditions
- Crohn Disease, Colitis, Ulcerative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Janssen Cilag S.A.S.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 31 Jul 2018 (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 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]).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease (IBD) Participants with EIMs and/or IMIDs | – | Drug: UstekinumabIBD (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. |
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 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).
Key inclusion criteria (5 listed)
- With a confirmed diagnosis of CD or UC
- With at least one EIM of interest (cutaneous: pyoderma gangrenosum; erythema nodosum, articular: axial spondyloarthritis and peripheral spondyloarthritis with and without psoriasis, dactylitis, enthesitis; ocular: uveitis) and/or at least one IMIDs of interest (cutaneous: psoriasis, atopic dermatitis, hidradenitis suppurativa), suspected or confirmed, that is active at the time of screening
- Starting ustekinumab as a biologic therapy for CD or UC treatment independently of their enrollment into the study
- Using ustekinumab according to the SmPC
- Only for participants with CD: has had an inadequate response with or lost response to or be intolerant to conventional therapy including azathioprine, 6-mercaptopurine or corticosteroids or; at least one tumor necrosis factor (TNF) blocker (adalimumab, infliximab). Only for participants with UC: Have had an inadequate response with, lost response to, or were intolerant to either conventional including azathioprine, 6-mercaptopurine or corticosteroids or a biologic
Key exclusion criteria (2 listed)
- Participants suffering from a psoriasis induced by a biological therapy at inclusion (including TNF blocker) or participant presenting an active psoriasis that was diagnosed before the time of inflammatory bowel disease (IBD) diagnosis
- Participants currently enrolled in an investigational study (or have been in the past 2 months) or are unwilling or not able to understand or provide their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabNo 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. | Drug | Inflammatory Bowel Disease (IBD) Participants with EIMs and/or IMIDs |
Primary outcome
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
Time frame: 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).
14 secondary outcomes
Percentage of Participants with Change from Baseline in Clinical Response for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Time frame: Baseline, Week 16 and Week 24
Percentage of Participants Achieving Remission for CD as Measured by HBI
Time frame: Up to Week 24
Change from Baseline in Partial Mayo Score
Time frame: Baseline, Week 16 and Week 24
Percentage of Participants Achieving Remission for UC as Measured by Partial Mayo Score (Score of <=2)
Time frame: Up to Week 24
Change from Baseline in the Presence of Extra Intestinal Manifestations (EIMS) or Immune-Mediated Inflammatory Diseases (IMIDs)
Time frame: Baseline and Week 24
Work Productivity and Activity Impairment (WPAI) Questionnaire
Time frame: Baseline, Weeks 16 and Week 24
Short Inflammatory Bowel Disease Questionnaire Score (Short IBDQ)
Time frame: Baseline, Weeks 16 and 24
Functional Assessment of Chronic Illness Therapy Scale (FACIT)
Time frame: Baseline, Weeks 16 and 24
Inflammatory Bowel Disease-Disability Index (IBD-DI)
Time frame: Baseline, Weeks 16 and 24
Number of Participants with Adverse Events
Time frame: Up to 37 weeks
Number of IBD Related Medical Visits
Time frame: Week 24
Number of Days of IBD Related Hospitalization with Surgery
Time frame: Week 24
Number of Days of IBD Related Hospitalization Without Surgery
Time frame: Week 24
Number of IBD Related Emergency Visits
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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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. This study is not recruiting at the moment.
Janssen Cilag S.A.S., France Clinical Trial study director
Janssen Cilag S.A.S.
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 Crohn Disease and Colitis, Ulcerative, run by Janssen Cilag S.A.S. at 1 site in France.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 27 Apr 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 24). 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 27 Apr 2025.