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

NCT02986724 | Completed

• 1 other identifier: Vedolizumab-4017
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With UC Achieving Clinical Response Based on Partial Mayo Score

  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.

  Baseline up to 52 Weeks

• Percentage of Participants With CD Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)

  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.

  Baseline up to 52 Weeks

• Number of Bio-naïve Participants Reporting One or More Treatment-emergent Adverse Events

  Baseline up to 52 Weeks

Secondary Outcomes (5)

• Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score

  up to 52 weeks from start of another biological therapy

• Percentage of Participants With CD Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI)

  up to 52 weeks from start of another biological therapy

• Percentage of Participants With UC Achieving Durable Clinical Response Based on Partial Mayo Score

  up to 52 weeks from start of another biological therapy

• 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

• 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

Study Arms (1)

Vedolizumab

Bio-naïve participants with UC or CD will be treated with vedolizumab as per local prescriptions from physician in routine medical practice for up to 52 Week. Participants who fail on vedolizumab may be switched during the study to another biologic treatment as prescribed by the physician during routine medical practice for up to 52 Weeks.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Biologically naïve participants with UC or CD undergoing treatment with Vedolizumab (Entyvio) will be evaluated for safety and efficacy.

You may not qualify if:

• Participant is enrolled in a clinical trial in which treatment for UC or CD is managed through a protocol,
• Prior treatment with a biologic agent,
• Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Innsbruck, Austria

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: January 4, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)