Colitis, UlcerativeNCT03535649
A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
An observational study of Colitis, Ulcerative, run by Takeda at 15 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colitis, Ulcerative
- Type of treatment
- Injection or infusion
- How many people
- 105 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 17 Aug 2017to 18 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1. Moderately to severely active UC and having failed TNF-alpha antagonist therapy.
Who cannot join
- Was treated with vedolizumab intravenous outside of the locally approved label in South Korea.
- Was enrolled in an Interventional Intestinal Bowel Disease clinical trial at time of using vedolizumab intravenous.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Inje University Haeundae Paik Hospita
Busan, 48108
Dankook University Hospital
Cheonan-si, Chungcheongnam-do, 31116
Kyungpook National University Hospital
Daegu, 41944
Youngnam University Hospital
Daegu, 42415
Goo Hospital
Daegu, 42644
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon, 34943
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Kyung Hee University Hospital
Seoul, 2447
Seoul National University Hospital
Seoul, 3080
Kangbuk Samsung Hospital
Seoul, 3181
Severance Hospital, Yonsei University Health System
Seoul, 3722
Asan Medical Center
Seoul, 5505
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 6273
Samsung Medical Center
Seoul, 6351
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
About this study
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
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.
Read the 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.
- Conditions
- Colitis, Ulcerative
- Keywords
- Drug therapy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab | Participants diagnosed with moderate to severe active UC and having failed tumor necrosis factor alpha (TNF alpha) antagonist therapy and who have initiated vedolizumab intravenous treatment between 17 August 2017 and the date when at least 100 cases are collected from approximately 15 participating sites will be observed from the date of UC diagnosis until the date when participant is enrolled into the study or until the end of treatment or death of participants or lost-to-follow up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score
Clinical response based on partial Mayo score was defined as a reduction of at least 3 points and a decrease of at least 30 percent (%) from the baseline Mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.
Measured: Week 6
Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs)
Measured: 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)
Percentage of Participants With Pregnancy During the Study
Measured: 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 (3)
Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score
Clinical response was defined as a reduction of at least 3 points and a decrease of at least 30% from the baseline mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, 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. Here, higher scores indicated more severe disease.
Measured: Week 14
Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score
Clinical remission was defined as a total mayo score of less than or equal to (<=) 2 with no sub-score greater than (>) 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.
Measured: Weeks 6 and 14
Percentage of Participants With Mucosal Healing at Weeks 6 and 14
Mucosal healing was defined as Mayo endoscopic sub-score of 0 or 1 compared to baseline. Mayo score was an instrument designed to measure disease activity of UC. Endoscopic findings was a sub-score of complete Mayo score, which ranges from 0 to 3 (0= Normal or inactive disease; 1= Mild disease; 2= Moderate disease; 3= Severe disease), with higher scores indicating more severe disease.
Measured: Weeks 6 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start17 Aug 2017
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535649
- Sponsor's protocol ID
- Vedolizumab-5045
- Other IDs
- U1111-1208-5399
- Status last verified
- Dec 2019
- First submitted
- 14 May 2018
- Last updated
- 23 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03535649
- Acronym / sponsor ID
- Vedolizumab-5045
- Conditions
- Colitis, Ulcerative
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Posted 23 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab | – | –Participants diagnosed with moderate to severe active UC and having failed tumor necrosis factor alpha (TNF alpha) antagonist therapy and who have initiated vedolizumab intravenous treatment between 17 August 2017 and the date when at least 100 cases are collected from approximately 15 participating sites will be observed from the date of UC diagnosis until the date when participant is enrolled into the study or until the end of treatment or death of participants or lost-to-follow up. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Moderately to severely active UC and having failed TNF-alpha antagonist therapy.
Key exclusion criteria (2 listed)
- Was treated with vedolizumab intravenous outside of the locally approved label in South Korea.
- Was enrolled in an Interventional Intestinal Bowel Disease clinical trial at time of using vedolizumab intravenous.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score
Time frame: Week 6
Clinical response based on partial Mayo score was defined as a reduction of at least 3 points and a decrease of at least 30 percent (%) from the baseline Mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.
Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs)
Time frame: 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)
Percentage of Participants With Pregnancy During the Study
Time frame: 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)
3 secondary outcomes
Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score
Time frame: Week 14
Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score
Time frame: Weeks 6 and 14
Percentage of Participants With Mucosal Healing at Weeks 6 and 14
Time frame: Weeks 6 and 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Colitis, Ulcerative
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colitis, Ulcerative, run by Takeda at 15 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score (time frame: Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.