Crohn DiseasePROSENCT03495973
Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease
An observational study of Crohn Disease, run by Janssen-Cilag Ltd. at 1 site in Sweden.
Trial summary
The main purpose of this study is to assess ustekinumab's ability to induce clinical response and remission ("effectiveness") at Week 16 and remission at Week 52 and Week 104 in participants with Crohn's disease (CD). Response and remission will be assessed using clinical parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Ustekinumab
- How many people
- 114 participants
- Where
- 1 siteSweden
- Study dates
- 25 Oct 2017to 22 Nov 2020
- 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: Participants with a confirmed Crohn's disease (CD) aged over 18 years treated with ustekinumab.
Who may be able to join
- Participant has a diagnosis of CD confirmed by investigator
- Participants with active CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic therapy or have medical contraindications to such therapies
- The participant must sign informed consent before enrollment in the study. The consent form permits extraction of data from SWIBREG at baseline and during participation of the study and linkages to the Patient Registry (Patientregistret), SCB's registry USA for occupational details (Longitudinell integrationsdatabas for sjukforsakrings- och arbetsmarknadsstudi er), the Social Insurance registry on long-term sick leave (Forsakringskassans register gallande sjukskrivningar) and the Prescription registry (Lakemedelsregistret)
- The participant must have been initiated on treatment with ustekinumab within the last 2 weeks (that is including those who already discontinued) or started on ustekinumab treatment less than (<) 3 months ago if treatment start was documented in SWIBREG within 2 weeks of onset and has a record of Harvey Bradshaw Index (HBI) when starting ustekinumab
Who cannot join
- The participant is enrolled in a clinical trial (randomized or non-randomized) in which the treatment of CD is dictated by a study protocol. If the participant is participating in another observational study (non-interventional), the participant may be included in this observational study
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the start of the study or the first data collection time point
- Participants who started ustekinumab despite contraindications for use
- Participants with planned stop of treatment with ustekinumab within 24 months from onset of treatment, that is bridging to other treatment or pregnancy planned
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE)
The main purpose of this study is to assess ustekinumab's ability to induce clinical response and remission ("effectiveness") at Week 16 and remission at Week 52 and Week 104 in participants with Crohn's disease (CD). Response and remission will be assessed using clinical parameters. Retention rate at week 52 and 104 will also be studied.
- Conditions
- Crohn Disease
- Being tested
- Ustekinumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Participants that are initiated on treatment with ustekinumab and are registered in Swibreg will be recruited into the cohort. All aspects of treatment and clinical management of participants will be in accordance with local clinical practice and applicable local regulations, and at the discretion of the participating physician.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Crohn's Disease (CD) | Participants with CD will be assessed for the effectiveness of ustekinumab in accordance with national guidelines and routine standard of care. Data will be prospectively collected with the aid of the Swedish inflammatory bowel disease (IBD) registry, SWIBREG and medical records of each participant. Data will also be collected retrospectively from SWIBREG and other databases including national databases such as the participant registry in which cases the national databases will be considered source data. Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Clinical Response at Week 16, Based on Harvey Bradshaw Index (HBI)
Clinical response for Crohn's disease (CD) is assessed by Harvey Bradshaw Index (HBI) and is defined as decrease of 3 points in baseline HBI score. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
Measured: Week 16
Percentage of Participants with Clinical Remission at Week 16, Based on HBI
Clinical remission for CD is assessed by HBI and is defined as HBI less than (<)5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score indicates: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
Measured: Week 16
Percentage of Participants with Clinical Remission at Week 52, Based on HBI
Clinical remission for CD is assessed by HBI and is defined as HBI <5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
Measured: Week 52
Percentage of Participants with Clinical Remission at Week 104, Based on HBI
Clinical remission for CD is assessed by HBI and is defined as HBI <5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
Measured: Week 104
Secondary outcomes (31)
Percentage of Participants with Clinical Response at Week 52 and 104, Based on HBI
Clinical response for CD is assessed by HBI and is defined as decrease of 3 points in baseline HBI score. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
Measured: Week 52 and 104
Percentage of Participants with Clinical Remission at Week 52 and 104 who are Remitters at 16 Weeks
Clinical remission for CD is assessed by HBI and is defined as HBI <5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
Measured: Week 52 and 104
Percentage of Participants with Clinical Remission at Week 104 who are Remitters at 52 Weeks
Clinical remission for CD is assessed by HBI and is defined as HBI <5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
Measured: Week 104
Percentage of Participants with Clinical Remission at Week 52 and 104 who are Responders at 16 Weeks
Clinical remission for CD is assessed by HBI and is defined as HBI <5. Responders are defined as the participants with decrease of 3 points in baseline HBI score. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease.
Measured: Week 52 and 104
Percentage of Participants in Clinical Remission Overtime
Clinical remission for CD is assessed by HBI and is defined as HBI <5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease.
Measured: Up to Week 104
Percentage of Participants with Corticosteroid Free Remission at Week 52 and 104
Participants on corticosteroids at baseline will be analyzed according to the percentage of participants in remission at week 52 and 104 without corticosteroids to assess corticosteroids free remission.
Measured: Week 52 and 104
Participant's Time off Corticosteroids
Duration for which participants were off from corticosteroids will be determined.
Measured: Up to week 104
Percentage of Participants in Every 12 weeks/8 weeks (q12 w/q8 w) maintenance groups at Week 16
Percentage of participants in q12 w/q8 w maintenance groups will be determined at Week 16.
Measured: Week 16
Percentage of Participants on Initial q12 w Maintenance Dose Escalated from q12 w to q8 w in Year 1 and 2
Percentage of participants on initial q12 maintenance dose escalated from q12 w to q8 w in Year 1 and 2 will be determined.
Measured: Year 1 and 2
Percentage of Participants with Dose Optimization
Percentage of participants with dose optimized to other dose than 90 milligram (mg) q8 w/q12 w in maintenance in Year 1 and 2 will be determined.
Measured: Year 1 and 2
Average Maintenance Dose per Month
Average maintenance dose (in mg) taken per month will be determined.
Measured: Week 52 and 104
Mean Change from Baseline in Fecal Calprotectin (fCal) Levels at Week 16, 52 and 104
Mean change from baseline in fCal (inflammatory biomarker) levels will be determined.
Measured: Baseline, Week 16, 52 and 104
Mean Change from Baseline in C-reactive Protein (CRP) Levels at Week 16, 52 and 104
Mean change from baseline in C-reactive protein (CRP) (inflammatory biomarker) levels will be determined.
Measured: Baseline, Week 16, 52 and 104
Percentage of Participants with fCal Less Than (<)250 milligram per kilogram (mg/kg)
Percentage of participants with fCal <250 mg/kg will be determined.
Measured: Week 16, 52 and 104
Percentage of Participants with fCal levels <250 mg/kg at Week 16, 52 and 104
Percentage of participants with fCal levels <250 mg/kg at Week 16, 52 and 104 will be determined in total and amongst participants with fCal levels greater than (>)250 mg/kg at baseline.
Measured: Week 16, 52 and 104
Percentage of Participants with Normalization of Plasma-CRP (P-CRP)
Percentage of participants with normalization of P-CRP in in participants with abnormal P-CRP at baseline will be reported. Normalization of P-CRP is defined as the high-sensitive (Hs)-CRP level <3 milligram per Liter (mg/L) or CRP below threshold of abnormal CRP concentration.
Measured: Week 16, 52 and 104
Change from Baseline in Short Health Scale (SHS) Score at Week 16, 52 and 104
Quality of life will be assessed by SHS score. SHS is a health related quality of life (HRQoL) questionnaire in which the participants rate the disease impact on 4 important aspects of subjective health (symptoms, function, worry, and general well-being). Responses are scored on 100-mm visual analogue scales and presented as individual scores for each of the four questions. The scores are then added for a total score. Total score ranges from 0 (low disease activity) to 100 (high disease activity).
Measured: Baseline, Week 16, 52 and 104
Change from Baseline in EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire at Week 16, 52 and 104
Quality of life will be assessed by EQ-5D-5L score. The EQ-5D-5L descriptive system comprises following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of 5 dimension is divided into 5 levels of perceived problems (Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems, and Level 5: extreme problems). The participant selects an answer for each of 5 dimensions considering response that best matches his or her health "today". The descriptive system can be represented as a health state.
Measured: Baseline, Week 16, 52 and 104
Change from Baseline in EQ-5D-5L Visual Analog Scale (VAS) at Week 16, 52 and 104
The EQ-VAS self-rating scale records respondent's own assessment of his or her overall health status at time of completion, on a scale of 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Baseline, Week 16, 52 and 104
Change from Baseline in the Presence of Extra Intestinal Manifestations at Week 16, 52 and 104
Change in the presence of extra intestinal manifestations, that is arthralgia, peripheral arthritis, anchylosing spondylitis, uveitis, erythema nodosum, pyoderma gangrenosum, primary sclerosing cholangitis, psoriatic arthritis and psoriasis will be determined.
Measured: Baseline, Week 16, 52 and 104
Healthcare Resource: Number of Imaging Procedures
Number of imaging procedures completed as a part of healthcare resources used in participants will be reported.
Measured: Up to week 104
Healthcare Resource: Number of Laboratory Test
Number of Laboratory tests completed as a part of healthcare resources used in participants will be reported.
Measured: Up to Week 104
Healthcare Resource: Number of Surgical Procedures
Number of surgical procedures completed as a part of healthcare resources used in participants will be reported.
Measured: Up to Week 104
Healthcare Resource: Number of Dual Energy X-ray Absorptiometry (DEXA) Scans
Number of DEXA scans performed as a part of healthcare resources used will be reported.
Measured: Up to Week 104
Healthcare Resource: Number of Participants with Endoscopies Performed
Number of participants with endoscopies performed as a part of healthcare resources used will be reported.
Measured: Up to Week 104
Healthcare Resource: Number of Days of Hospitalization
Number of days of hospitalization (defined as number of days from the day of admission to discharge) as a part of healthcare resources used will be reported.
Measured: Up to Week 104
Healthcare Resource: Number of Sick-Leaves
Number of sick-leaves taken by participants as a part of healthcare resources used will be reported.
Measured: Up to Week 104
Healthcare Resource: Number of Participants Using Concomitant Treatment
Number of participants using concomitant treatment as a part of healthcare resources used will be reported.
Measured: Up to Week 104
Healthcare Resource: Number of Health Care Visits
Number of health care visits to nurses, dieticians and doctors as a part of healthcare resources used will be reported.
Measured: Up to Week 104
Number of Participants with Malignancy
Number of participants with malignancy developed during the study will be reported.
Measured: Up to Week 104
Number of Participants Requiring Antibiotics for any Infection Occurred During the Study
Number of participants requiring antibiotics for any infection occurred during the study will be reported.
Measured: Up to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start25 Oct 2017
- Primary completion22 Nov 2020
- Study completion22 Nov 2020
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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495973
- Sponsor's protocol ID
- CR108430
- Other IDs
- CNTO1275CRD4006
- Acronym
- PROSE
- Status last verified
- Jan 2025
- First submitted
- 28 Mar 2018
- Last updated
- 3 Feb 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 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE)
- ClinicalTrials.gov ID
- NCT03495973
- Acronym / sponsor ID
- PROSE / CR108430
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 22 Nov 2020 (actual)
- Study completion
- 22 Nov 2020 (actual)
- First posted
- 12 Apr 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 main purpose of this study is to assess ustekinumab's ability to induce clinical response and remission ("effectiveness") at Week 16 and remission at Week 52 and Week 104 in participants with Crohn's disease (CD). Response and remission will be assessed using clinical parameters. Retention rate at week 52 and 104 will also be studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Crohn's Disease (CD) | – | Drug: UstekinumabParticipants with CD will be assessed for the effectiveness of ustekinumab in accordance with national guidelines and routine standard of care. Data will be prospectively collected with the aid of the Swedish inflammatory bowel disease (IBD) registry, SWIBREG and medical records of each participant. Data will also be collected retrospectively from SWIBREG and other databases including national databases such as the participant registry in which cases the national databases will be considered source data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a confirmed Crohn's disease (CD) aged over 18 years treated with ustekinumab.
Key inclusion criteria (4 listed)
- Participant has a diagnosis of CD confirmed by investigator
- Participants with active CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic therapy or have medical contraindications to such therapies
- The participant must sign informed consent before enrollment in the study. The consent form permits extraction of data from SWIBREG at baseline and during participation of the study and linkages to the Patient Registry (Patientregistret), SCB's registry USA for occupational details (Longitudinell integrationsdatabas for sjukforsakrings- och arbetsmarknadsstudi er), the Social Insurance registry on long-term sick leave (Forsakringskassans register gallande sjukskrivningar) and the Prescription registry (Lakemedelsregistret)
- The participant must have been initiated on treatment with ustekinumab within the last 2 weeks (that is including those who already discontinued) or started on ustekinumab treatment less than (<) 3 months ago if treatment start was documented in SWIBREG within 2 weeks of onset and has a record of Harvey Bradshaw Index (HBI) when starting ustekinumab
Key exclusion criteria (4 listed)
- The participant is enrolled in a clinical trial (randomized or non-randomized) in which the treatment of CD is dictated by a study protocol. If the participant is participating in another observational study (non-interventional), the participant may be included in this observational study
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the start of the study or the first data collection time point
- Participants who started ustekinumab despite contraindications for use
- Participants with planned stop of treatment with ustekinumab within 24 months from onset of treatment, that is bridging to other treatment or pregnancy planned
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 |
|---|---|---|
| UstekinumabParticipants that are initiated on treatment with ustekinumab and are registered in Swibreg will be recruited into the cohort. All aspects of treatment and clinical management of participants will be in accordance with local clinical practice and applicable local regulations, and at the discretion of the participating physician. | Drug | Participants with Crohn's Disease (CD) |
Primary outcome
Percentage of Participants with Clinical Response at Week 16, Based on Harvey Bradshaw Index (HBI)
Time frame: Week 16
Clinical response for Crohn's disease (CD) is assessed by Harvey Bradshaw Index (HBI) and is defined as decrease of 3 points in baseline HBI score. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
Percentage of Participants with Clinical Remission at Week 16, Based on HBI
Time frame: Week 16
Clinical remission for CD is assessed by HBI and is defined as HBI less than (<)5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score indicates: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
Percentage of Participants with Clinical Remission at Week 52, Based on HBI
Time frame: Week 52
Clinical remission for CD is assessed by HBI and is defined as HBI <5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
Percentage of Participants with Clinical Remission at Week 104, Based on HBI
Time frame: Week 104
Clinical remission for CD is assessed by HBI and is defined as HBI <5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).
31 secondary outcomes
Percentage of Participants with Clinical Response at Week 52 and 104, Based on HBI
Time frame: Week 52 and 104
Percentage of Participants with Clinical Remission at Week 52 and 104 who are Remitters at 16 Weeks
Time frame: Week 52 and 104
Percentage of Participants with Clinical Remission at Week 104 who are Remitters at 52 Weeks
Time frame: Week 104
Percentage of Participants with Clinical Remission at Week 52 and 104 who are Responders at 16 Weeks
Time frame: Week 52 and 104
Percentage of Participants in Clinical Remission Overtime
Time frame: Up to Week 104
Percentage of Participants with Corticosteroid Free Remission at Week 52 and 104
Time frame: Week 52 and 104
Participant's Time off Corticosteroids
Time frame: Up to week 104
Percentage of Participants in Every 12 weeks/8 weeks (q12 w/q8 w) maintenance groups at Week 16
Time frame: Week 16
Percentage of Participants on Initial q12 w Maintenance Dose Escalated from q12 w to q8 w in Year 1 and 2
Time frame: Year 1 and 2
Percentage of Participants with Dose Optimization
Time frame: Year 1 and 2
Average Maintenance Dose per Month
Time frame: Week 52 and 104
Mean Change from Baseline in Fecal Calprotectin (fCal) Levels at Week 16, 52 and 104
Time frame: Baseline, Week 16, 52 and 104
Mean Change from Baseline in C-reactive Protein (CRP) Levels at Week 16, 52 and 104
Time frame: Baseline, Week 16, 52 and 104
Percentage of Participants with fCal Less Than (<)250 milligram per kilogram (mg/kg)
Time frame: Week 16, 52 and 104
Percentage of Participants with fCal levels <250 mg/kg at Week 16, 52 and 104
Time frame: Week 16, 52 and 104
Percentage of Participants with Normalization of Plasma-CRP (P-CRP)
Time frame: Week 16, 52 and 104
Change from Baseline in Short Health Scale (SHS) Score at Week 16, 52 and 104
Time frame: Baseline, Week 16, 52 and 104
Change from Baseline in EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire at Week 16, 52 and 104
Time frame: Baseline, Week 16, 52 and 104
Change from Baseline in EQ-5D-5L Visual Analog Scale (VAS) at Week 16, 52 and 104
Time frame: Baseline, Week 16, 52 and 104
Change from Baseline in the Presence of Extra Intestinal Manifestations at Week 16, 52 and 104
Time frame: Baseline, Week 16, 52 and 104
Healthcare Resource: Number of Imaging Procedures
Time frame: Up to week 104
Healthcare Resource: Number of Laboratory Test
Time frame: Up to Week 104
Healthcare Resource: Number of Surgical Procedures
Time frame: Up to Week 104
Healthcare Resource: Number of Dual Energy X-ray Absorptiometry (DEXA) Scans
Time frame: Up to Week 104
Healthcare Resource: Number of Participants with Endoscopies Performed
Time frame: Up to Week 104
Healthcare Resource: Number of Days of Hospitalization
Time frame: Up to Week 104
Healthcare Resource: Number of Sick-Leaves
Time frame: Up to Week 104
Healthcare Resource: Number of Participants Using Concomitant Treatment
Time frame: Up to Week 104
Healthcare Resource: Number of Health Care Visits
Time frame: Up to Week 104
Number of Participants with Malignancy
Time frame: Up to Week 104
Number of Participants Requiring Antibiotics for any Infection Occurred During the Study
Time frame: Up to Week 104
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 3 Feb 2025.
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IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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 Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
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, run by Janssen-Cilag Ltd. at 1 site in Sweden.
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 4 inclusion and 4 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 3 Feb 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 Sweden. 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 with Clinical Response at Week 16, Based on Harvey Bradshaw Index (HBI) (time frame: Week 16). The study lists 4 primary outcomes in all. 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 3 Feb 2025.