Clinical trial NCT02986724: A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants With Ulcerative Colitis (UC) or Crohn´s Disease (CD)
Official title: CHRONOS - A Multicenter, Non - Interventional Study to Observe the Safety and Efficacy of Vedolizumab (Entyvio) in Patients With Ulcerative Colitis or Crohn´s Disease That Are Biologic naïve, Observed in Daily Practice in Austria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-12-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria

1 Initiating vedolizumab for moderately to severely active UC or CD. Exclusion Criteria

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

Primary outcomes:
measure: Percentage of Participants With UC Achieving Clinical Response Based on Partial Mayo Score
timeFrame: Baseline up to 52 Weeks
measure: Percentage of Participants With CD Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)
timeFrame: Baseline up to 52 Weeks
measure: Number of Bio-naïve Participants Reporting One or More Treatment-emergent Adverse Events
timeFrame: Baseline up to 52 Weeks
Secondary outcomes:
measure: Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score
timeFrame: up to 52 weeks from start of another biological therapy
measure: Percentage of Participants With CD Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI)
timeFrame: up to 52 weeks from start of another biological therapy
measure: Percentage of Participants With UC Achieving Durable Clinical Response Based on Partial Mayo Score
timeFrame: up to 52 weeks from start of another biological therapy
measure: Percentage of Participants With CD Achieving Durable Clinical Response Based on Harvey-Bradshaw Index (HBI)
timeFrame: up to 52 weeks from start of another biological therapy
measure: Number of Participants who Failed Vedolizumab Therapy Reporting One or More Treatment-emergent Adverse Events
timeFrame: up to 52 weeks from start of another biological therapy
Other outcomes:
Locations:
city: Innsbruck
country: Austria
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: