Clinical trial NCT03535649: A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
Official title: Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis Korean Patients: a Multicenter Post-marketing Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colitis, Ulcerative
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 105
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with moderate to severe UC, having failed TNF-alpha antagonist therapy and who have initiated treatment with vedolizumab intravenous between 17 August 2017 and up until 100 participants are enrolled.

Brief summary: The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.

Detailed description: This is a post-marketing, non-interventional study of participants with moderate to severe UC. The study will review medical records of participants who have initiated medical treatment with vedolizumab intravenous during the defined eligibility period under routine clinical practice to provide the real world data on the effectiveness and safety of vedolizumab intravenous.

The study will enroll approximately 100 participants. All participants will be enrolled in one observational group: Vedolizumab

Both retrospective and prospective data will be collected in the index period, with prospective data collected for treatment baseline visit and follow up visits.

The multi-center trial will be conducted in Republic of Korea. The overall duration of study will be approximately 15 months.

Eligibility criteria: Inclusion Criteria:

1. Moderately to severely active UC and having failed TNF-alpha antagonist therapy.

Exclusion Criteria:

1. Was treated with vedolizumab intravenous outside of the locally approved label in South Korea.
2. Was enrolled in an Interventional Intestinal Bowel Disease clinical trial at time of using vedolizumab intravenous.

Primary outcomes:
measure: Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score
timeFrame: Week 6
measure: Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs)
timeFrame: From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)
measure: Percentage of Participants With Pregnancy During the Study
timeFrame: From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)
Secondary outcomes:
measure: Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score
timeFrame: Week 14
measure: Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score
timeFrame: Weeks 6 and 14
measure: Percentage of Participants With Mucosal Healing at Weeks 6 and 14
timeFrame: Weeks 6 and 14
Other outcomes:
Locations:
city: Cheonan-si
country: Korea, Republic of
facility: Dankook University Hospital
state: Chungcheongnam-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospita
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Youngnam University Hospital
city: Daegu
country: Korea, Republic of
facility: Goo Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: