A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants With Ulcerative Colitis (UC) or Crohn´s Disease (CD)

Completed

• Conditions: Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

• Registration Number: NCT02986724
• Lead Sponsor: Takeda

Brief Summary

The purpose of this non-interventional study (NIS) study is to assess further knowledge on the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in participants with CD and UC naive to biologics.

Detailed Description

The drug being tested in this prospective, observational study is called vedolizumab. Vedolizumab (Entyvio) is being used to treat people who have CD or UC. This study will look in the routine use of vedolizumab in inflammatory bowel disease therapy in participants with CD or UC who did not receive a biologic treatment before. The study will enroll approximately 150 participants. All participants enrolled in this will belong to one observational group: Vedolizumab.

Participants taking vedolizumab as per physician's prescription in routine clinical practice will be observed.

This multi-centre trial will be conducted in Austria. The overall time to participate in this study is 2 years. Participant taking vedolizumab in routine clinical practice will make multiple visits to the clinic at Baseline, Week 20 and 52. Once a participant is switched to subsequent biologic treatment upon failing treatment with vedolizumab, the switching date will be considered as new baseline followed by visits at Week 20 and 52.

Study Timeline

• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-08
• Study Start: 2017-01-04
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With CD Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)	Baseline up to 52 Weeks	Clinical response is defined as a decrease in HBI score of \>=3 points from baseline. HBI score is used to measure the disease activity of CD. It 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, where higher scores indicating more severe disease.
Percentage of Participants With UC Achieving Clinical Response Based on Partial Mayo Score	Baseline up to 52 Weeks	Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and \>=25% from baseline, with an accompanying decrease in rectal bleeding subscore of \>=1 point from baseline or absolute rectal bleeding subscore of \<=1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. Outcome measure is planned to be assessed in bio-naive participants who receive vedolizumab treatment.
Number of Bio-naïve Participants Reporting One or More Treatment-emergent Adverse Events	Baseline up to 52 Weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score	up to 52 weeks from start of another biological therapy	Clinical remission is defined as a partial Mayo score of \<=2 with no individual subscore \>1. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.
Percentage of Participants With CD Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI)	up to 52 weeks from start of another biological therapy	Clinical remission is defined as total HBI score of \<=4 points. HBI score is used to measure the disease activity of CD. It 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, where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.
Percentage of Participants With UC Achieving Durable Clinical Response Based on Partial Mayo Score	up to 52 weeks from start of another biological therapy	Durable clinical response is defined as clinical response at Week 104, where clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and \>=25% from baseline, with an accompanying decrease in rectal bleeding subscore of \>=1 point from baseline or absolute rectal bleeding subscore of \<=1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.
Percentage of Participants With CD Achieving Durable Clinical Response Based on Harvey-Bradshaw Index (HBI)	up to 52 weeks from start of another biological therapy	Durable clinical response is defined as clinical response at Week 104, where clinical response is defined as a decrease in HBI score of \>=3 points from baseline. HBI score is used to measure the disease activity of CD. It 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, where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.
Number of Participants who Failed Vedolizumab Therapy Reporting One or More Treatment-emergent Adverse Events	up to 52 weeks from start of another biological therapy