Crohn DiseaseEARLY-CDNCT04349449
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
An observational study of Crohn Disease, run by Takeda at 14 sites in Canada.
Trial summary
The purpose of this study is to describe physician-reported clinical effectiveness outcomes, as determined by Harvey-Bradshaw Index (HBI) assessment, in biologic-naive participants with CD over 12 months following treatment initiation with vedolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 14 sitesCanada
- Study dates
- 30 Sep 2020to 30 Nov 2022
- 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: Biologic-naive participants diagnosed with moderately to severely active CD who have initiated treatment with vedolizumab under standard clinical care will be observed.
Who may be able to join
- Is enrolled in Takeda's participant support program prior to receiving vedolizumab.
- Has a diagnosis of moderately-to-severely active CD, as documented in the medical records.
- Scheduled for initial vedolizumab treatment per usual care recommendation.
- Was biologic-naive at time of initiating vedolizumab treatment.
Who cannot join
- Was prescribed vedolizumab as part of a clinical study.
- Has isolated and active perianal disease in the absence of luminal CD.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
Barrie GI Associates
Barrie, Ontario, L4M 7G1
REGIONAL HEALTH AUTHORITY B doing business as HORIZON HEALTH NETWORK
Fredericton, New Brunswick, E3B 4R3
Nova ScotiaHealth Authority
Halifax, Nova Scotia, B3V 1V7
Kelowna GI Associates
Kelowna, British Columbia, V1Y 6J6
Lawson Health Research Institute a joint venture of London Health Science Centre Research Inc., Lawson Research Institute.
London, Ontario, N6C 2R5
Research Institute McGill University Health Centre (RI-MUHC)
Montreal, Quebec, H3G 1A4
Fraser Clinical Trials Inc.
New Westminster, British Columbia, V3L 3W4
Girish Bajaj MPC
Oakville, Ontario, L6H 7v7
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
Centre integre universitaire de sante et de services sociaux de l'Estrie Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1G 2E8
Sinai Health System
Toronto, Ontario, M5G 1X5
Kensington Cancer Screening Clinic
Toronto, Ontario, M5T 3A9
Toronto Immune and Digestive Health Institute
Toronto, Ontario, M6A 3B4
The Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
About this study
Official title: A Prospective Observational Study of ENTYVIO Management in Crohn's Disease in Canada: Real-World Experience and Patient-Reported Outcomes
The purpose of this study is to describe physician-reported clinical effectiveness outcomes, as determined by Harvey-Bradshaw Index (HBI) assessment, in biologic-naive participants with CD over 12 months following treatment initiation with vedolizumab.
Read the detailed description
This is a non-interventional, single-cohort, prospective study of participants with moderate to severe CD. The study will review medical charts with prospective patient-reported outcome measures to provide real-world data to describe clinical outcomes and participant-reported symptom experience over 12 months following vedolizumab treatment initiation.
The study will enroll approximately 140 participants. All participants will be enrolled in one observational group:
- Vedolizumab
This multicenter trial will be conducted in Canada. The overall duration of study will be approximately 24 months, including participant's enrolment period of 12 months and follow-up data collection period of 12 months.
- Conditions
- Crohn Disease
- Keywords
- Drug Therapy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab Participants | Participants diagnosed with moderate to severe CD from approximately 20 investigational sites will be observed over a period of 12 months after initiation of treatment with vedolizumab, intravenous infusion under standard clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Clinical Remission at Month 12
Clinical remission is defined as HBI less than or equal to (<=) 5. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0= very well to 4= terrible), abdominal pain (0=none to 3= severe), number of liquid or soft stools/ previous day, abdominal mass (0= none to 3= definite and tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, where score <5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and greater than (>) 16 = severe disease activity.
Measured: Month 12
Secondary outcomes (22)
Change From Baseline in HBI at Month 12
HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0= very well to 4= terrible), abdominal pain (0=none to 3= severe), number of liquid or soft stools/previous day, abdominal mass (0= none to 3= definite and tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, where score <5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and >16 = severe disease activity.
Measured: Baseline up to Month 12
Change From Baseline in Physician Global Assessment (PGA) at Month 12
PGA score is used to measure disease activity of CD. Score ranges from 0 to 3, where 0 = normal condition; 1- mild disease condition; 2= moderate disease condition; and 3 = severe disease condition.
Measured: Baseline up to Month 12
Change From Baseline in Patient-reported Outcome (PRO) Using the Two-item (PRO-2) at Month 12
The PRO2 is comprised of the stool frequency and abdominal pain components of the Crohn's Disease Activity Index (CDAI). The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score. The average daily number of stools and abdominal pain score (with 0 indicating no pain and 4 indicating severe pain) over the past seven days are weighted according to the CDAI multiplication factors (2 for stool frequency and 5 for abdominal pain).
Measured: Baseline and Month 12
Change From Baseline in C-reactive Protein (CRP) Level at Month 12
Comparison of absolute change in CRP from baseline to Month 12. CRP is produced by the liver. The level of CRP rises when there is inflammation throughout the body.
Measured: Baseline and Month 12
Percentage of Participants in Remission as Determined by CRP Measurements <5 Milligram per Liter (mg/L) at Month 12
Remission is defined as CRP <5 mg/L.
Measured: Month 12
Change From Baseline in Fecal Calprotectin (FCP) Levels at Month 12
Measured: Baseline and Month 12
Percentage of Participants in Remission as Determined by FCP Measurements (FCP < 50 milligram per kilogram [mg/Kg]) at Month 12
Remission is defined as FCP <50 mg/kg.
Measured: Month 12
Percentage of Participants With Endoscopic Improvement at Month 12 as Determined by Simple Endoscopic Score for Crohn's Disease (SES-CD) Values or Qualitative Physician Assessment of Disease Severity
The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. The Physician's Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better).
Measured: Baseline and Month 12
Number of Participants Categorized by Participant Demographics, Clinical Characteristics and Disease Phenotype
Measured: Month 12
Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Score at Month 12
The WPAI-SHP assess the impact of CD on work productivity and daily activities, and classroom impairment during the previous 7 days. The questionnaire consists of questions about the number of hours missed from work, hours worked, and the extent to which work productivity and regular daily activities were affected. Scores will be calculated as percentages of hours worked and percentages of productivity at work on work days. An overall work productivity score will be computed by multiplying the percentage of work time by the percentage productivity at work; the higher the scores, the better work productivity and activity performance.
Measured: Baseline, Month 12
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score at Month 12
The SIBDQ is a self-reported quantitative assessment of participant's health-related quality of life (HRQoL) in terms of physical, emotional, and social symptoms associated with IBD. The questionnaire relates to the past two weeks and consists of 10 questions about fatigue, social and leisure activities, pain, feelings of depression, and physical health issues. It consists of 7 point scale, with 1 indicating severity and 7 indicating the lack of a problem. The overall score can range from 10-70, with higher scores signifying better HRQoL.
Measured: Baseline and Month 12
Change From Baseline in Corticosteroid Dose at Month 12
Measured: Baseline and Month 12
Change From Baseline in Immunomodulator Dose at Month 12
Measured: Baseline and Month 12
Change From Baseline in the Percentage of Participants That are Steroid-free at Month 12
Measured: Baseline and Month 12
Change From Baseline in the Percentage of Participants That are Immunomodulator-free at Month 12
Measured: Baseline and Month 12
Number of Participants with Reporting one or More Adverse Events and Serious Adverse Events (SAEs)
Measured: Baseline up to Month 12
Number of Participants Based on CD-related Emergency Room (ER) Visits, Hospitalizations, or Surgeries
Measured: Baseline up to Month 12
Number of Participants that initiated Vedolizumab treatment and are still on Vedolizumab treatment at 12 months of follow-up
Measured: Baseline up to Month 12
Number of Participants With Reasons for Discontinuation of Vedolizumab Treatment
Measured: Baseline up to Month 12
Number of Participants Based on Subsequent Biologic Therapy Type
Measured: Baseline up to Month 12
Number of Participants that Received vedolizumab Dose Optimization
Dose optimization is defined as a change from every 8 weeks maintenance vedolizumab to any other schedule.
Measured: Baseline up to Month 12
Time to vedolizumab Dose Optimization
Dose optimization is defined as a change from every 8 weeks maintenance vedolizumab to any other schedule.
Measured: Baseline up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start30 Sep 2020 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Why it stopped: Business Decision (no enrollment)
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.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349449
- Sponsor's protocol ID
- Vedolizumab-4022
- Other IDs
- U1111-1217-6862, MACS-2017-102118
- Acronym
- EARLY-CD
- Status last verified
- Oct 2020
- First submitted
- 14 Apr 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of ENTYVIO Management in Crohn's Disease in Canada: Real-World Experience and Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT04349449
- Acronym / sponsor ID
- EARLY-CD / Vedolizumab-4022
- Conditions
- Crohn Disease
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business Decision (no enrollment)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 16 Apr 2020 (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 describe physician-reported clinical effectiveness outcomes, as determined by Harvey-Bradshaw Index (HBI) assessment, in biologic-naive participants with CD over 12 months following treatment initiation with vedolizumab.
Detailed description
This is a non-interventional, single-cohort, prospective study of participants with moderate to severe CD. The study will review medical charts with prospective patient-reported outcome measures to provide real-world data to describe clinical outcomes and participant-reported symptom experience over 12 months following vedolizumab treatment initiation.
The study will enroll approximately 140 participants. All participants will be enrolled in one observational group:
- Vedolizumab
This multicenter trial will be conducted in Canada. The overall duration of study will be approximately 24 months, including participant's enrolment period of 12 months and follow-up data collection period of 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab Participants | – | –Participants diagnosed with moderate to severe CD from approximately 20 investigational sites will be observed over a period of 12 months after initiation of treatment with vedolizumab, intravenous infusion under standard clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Biologic-naive participants diagnosed with moderately to severely active CD who have initiated treatment with vedolizumab under standard clinical care will be observed.
Key inclusion criteria (4 listed)
- Is enrolled in Takeda's participant support program prior to receiving vedolizumab.
- Has a diagnosis of moderately-to-severely active CD, as documented in the medical records.
- Scheduled for initial vedolizumab treatment per usual care recommendation.
- Was biologic-naive at time of initiating vedolizumab treatment.
Key exclusion criteria (2 listed)
- Was prescribed vedolizumab as part of a clinical study.
- Has isolated and active perianal disease in the absence of luminal CD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants in Clinical Remission at Month 12
Time frame: Month 12
Clinical remission is defined as HBI less than or equal to (<=) 5. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0= very well to 4= terrible), abdominal pain (0=none to 3= severe), number of liquid or soft stools/ previous day, abdominal mass (0= none to 3= definite and tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, where score <5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and greater than (>) 16 = severe disease activity.
22 secondary outcomes
Change From Baseline in HBI at Month 12
Time frame: Baseline up to Month 12
Change From Baseline in Physician Global Assessment (PGA) at Month 12
Time frame: Baseline up to Month 12
Change From Baseline in Patient-reported Outcome (PRO) Using the Two-item (PRO-2) at Month 12
Time frame: Baseline and Month 12
Change From Baseline in C-reactive Protein (CRP) Level at Month 12
Time frame: Baseline and Month 12
Percentage of Participants in Remission as Determined by CRP Measurements <5 Milligram per Liter (mg/L) at Month 12
Time frame: Month 12
Change From Baseline in Fecal Calprotectin (FCP) Levels at Month 12
Time frame: Baseline and Month 12
Percentage of Participants in Remission as Determined by FCP Measurements (FCP < 50 milligram per kilogram [mg/Kg]) at Month 12
Time frame: Month 12
Percentage of Participants With Endoscopic Improvement at Month 12 as Determined by Simple Endoscopic Score for Crohn's Disease (SES-CD) Values or Qualitative Physician Assessment of Disease Severity
Time frame: Baseline and Month 12
Number of Participants Categorized by Participant Demographics, Clinical Characteristics and Disease Phenotype
Time frame: Month 12
Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Score at Month 12
Time frame: Baseline, Month 12
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score at Month 12
Time frame: Baseline and Month 12
Change From Baseline in Corticosteroid Dose at Month 12
Time frame: Baseline and Month 12
Change From Baseline in Immunomodulator Dose at Month 12
Time frame: Baseline and Month 12
Change From Baseline in the Percentage of Participants That are Steroid-free at Month 12
Time frame: Baseline and Month 12
Change From Baseline in the Percentage of Participants That are Immunomodulator-free at Month 12
Time frame: Baseline and Month 12
Number of Participants with Reporting one or More Adverse Events and Serious Adverse Events (SAEs)
Time frame: Baseline up to Month 12
Number of Participants Based on CD-related Emergency Room (ER) Visits, Hospitalizations, or Surgeries
Time frame: Baseline up to Month 12
Number of Participants that initiated Vedolizumab treatment and are still on Vedolizumab treatment at 12 months of follow-up
Time frame: Baseline up to Month 12
Number of Participants With Reasons for Discontinuation of Vedolizumab Treatment
Time frame: Baseline up to Month 12
Number of Participants Based on Subsequent Biologic Therapy Type
Time frame: Baseline up to Month 12
Number of Participants that Received vedolizumab Dose Optimization
Time frame: Baseline up to Month 12
Time to vedolizumab Dose Optimization
Time frame: Baseline up to Month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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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.
Medical Director study director
Takeda
14 sites 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 Takeda at 14 sites in Canada.
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 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: withdrawn, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada. 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 was withdrawn before enrolling participants, so there are no results.
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 in Clinical Remission at Month 12 (time frame: Month 12). 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 6 Oct 2020.