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ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice (EARLY-CD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04349449
Recruitment Status : Withdrawn (Business Decision (no enrollment))
First Posted : April 16, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief 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.

Condition or disease
Crohn Disease

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of ENTYVIO Management in Crohn's Disease in Canada: Real-World Experience and Patient-Reported Outcomes
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Vedolizumab

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change From Baseline in HBI at Month 12 [ Time Frame: Baseline up to 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.

  2. Change From Baseline in Physician Global Assessment (PGA) at Month 12 [ Time Frame: Baseline up to 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.

  3. Change From Baseline in Patient-reported Outcome (PRO) Using the Two-item (PRO-2) at Month 12 [ Time Frame: Baseline and 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).

  4. Change From Baseline in C-reactive Protein (CRP) Level at Month 12 [ Time Frame: Baseline and 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.

  5. Percentage of Participants in Remission as Determined by CRP Measurements <5 Milligram per Liter (mg/L) at Month 12 [ Time Frame: Month 12 ]
    Remission is defined as CRP <5 mg/L.

  6. Change From Baseline in Fecal Calprotectin (FCP) Levels at Month 12 [ Time Frame: Baseline and Month 12 ]
  7. Percentage of Participants in Remission as Determined by FCP Measurements (FCP < 50 milligram per kilogram [mg/Kg]) at Month 12 [ Time Frame: Month 12 ]
    Remission is defined as FCP <50 mg/kg.

  8. 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 ]
    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).

  9. Number of Participants Categorized by Participant Demographics, Clinical Characteristics and Disease Phenotype [ Time Frame: Month 12 ]
  10. Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Score at Month 12 [ Time Frame: Baseline, 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.

  11. Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score at Month 12 [ Time Frame: Baseline and 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.

  12. Change From Baseline in Corticosteroid Dose at Month 12 [ Time Frame: Baseline and Month 12 ]
  13. Change From Baseline in Immunomodulator Dose at Month 12 [ Time Frame: Baseline and Month 12 ]
  14. Change From Baseline in the Percentage of Participants That are Steroid-free at Month 12 [ Time Frame: Baseline and Month 12 ]
  15. Change From Baseline in the Percentage of Participants That are Immunomodulator-free at Month 12 [ Time Frame: Baseline and Month 12 ]
  16. Number of Participants with Reporting one or More Adverse Events and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 12 ]
  17. Number of Participants Based on CD-related Emergency Room (ER) Visits, Hospitalizations, or Surgeries [ Time Frame: Baseline up to Month 12 ]
  18. 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 ]
  19. Number of Participants With Reasons for Discontinuation of Vedolizumab Treatment [ Time Frame: Baseline up to Month 12 ]
  20. Number of Participants Based on Subsequent Biologic Therapy Type [ Time Frame: Baseline up to Month 12 ]
  21. Number of Participants that Received vedolizumab Dose Optimization [ Time Frame: Baseline up to Month 12 ]
    Dose optimization is defined as a change from every 8 weeks maintenance vedolizumab to any other schedule.

  22. Time to vedolizumab Dose Optimization [ Time Frame: Baseline up to Month 12 ]
    Dose optimization is defined as a change from every 8 weeks maintenance vedolizumab to any other schedule.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Is enrolled in Takeda's participant support program prior to receiving vedolizumab.
  2. Has a diagnosis of moderately-to-severely active CD, as documented in the medical records.
  3. Scheduled for initial vedolizumab treatment per usual care recommendation.
  4. Was biologic-naive at time of initiating vedolizumab treatment.

Exclusion Criteria:

  1. Was prescribed vedolizumab as part of a clinical study.
  2. Has isolated and active perianal disease in the absence of luminal CD.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349449


Locations
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Canada, British Columbia
Kelowna GI Associates
Kelowna, British Columbia, Canada, V1Y 6J6
Fraser Clinical Trials Inc.
New Westminster, British Columbia, Canada, V3L 3W4
Canada, Manitoba
The Winnipeg Clinic
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, New Brunswick
REGIONAL HEALTH AUTHORITY B doing business as HORIZON HEALTH NETWORK
Fredericton, New Brunswick, Canada, E3B 4R3
Canada, Nova Scotia
Nova ScotiaHealth Authority
Halifax, Nova Scotia, Canada, B3V 1V7
Canada, Ontario
Barrie GI Associates
Barrie, Ontario, Canada, L4M 7G1
Lawson Health Research Institute a joint venture of London Health Science Centre Research Inc., Lawson Research Institute.
London, Ontario, Canada, N6C 2R5
Girish Bajaj MPC
Oakville, Ontario, Canada, L6H 7v7
Sinai Health System
Toronto, Ontario, Canada, M5G 1X5
Kensington Cancer Screening Clinic
Toronto, Ontario, Canada, M5T 3A9
Toronto Immune and Digestive Health Institute
Toronto, Ontario, Canada, M6A 3B4
Canada, Quebec
Research Institute McGill University Health Centre (RI-MUHC)
Montreal, Quebec, Canada, H3G 1A4
Centre integre universitaire de sante et de services sociaux de l'Estrie Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1G 2E8
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04349449    
Other Study ID Numbers: Vedolizumab-4022
U1111-1217-6862 ( Registry Identifier: WHO )
MACS-2017-102118 ( Other Identifier: Study ID )
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases