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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1208-5399 | Other Identifier | WHO |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 6 |
| Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs) | 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 | 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 | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
1. Moderately to severely active UC and having failed TNF-alpha antagonist therapy.
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dankook University Hospital | Cheonan-si | Chungcheongnam-do | 31116 | South Korea | ||
| Seoul National University Bundang Hospital |
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.
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Participants with a diagnosis of moderately to severely active ulcerative colitis (UC), having failed tumor necrosis factor-alpha (TNF-alpha) antagonist therapy and who have been prescribed vedolizumab intravenously under standard clinical practice were enrolled in this observational study.
Participants took part in the study at 13 investigative sites in South Korea from 17 August 2017 to 18 December 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vedolizumab | Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2018 | Dec 2, 2019 |
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| 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. | 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. | Weeks 6 and 14 |
| Seongnam-si |
| Gyeonggi-do |
| 13620 |
| South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Inje University Haeundae Paik Hospita | Busan | 48108 | South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Youngnam University Hospital | Daegu | 42415 | South Korea |
| Goo Hospital | Daegu | 42644 | South Korea |
| The Catholic University of Korea, Daejeon St. Mary's Hospital | Daejeon | 34943 | South Korea |
| Kyung Hee University Hospital | Seoul | 2447 | South Korea |
| Seoul National University Hospital | Seoul | 3080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 3181 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 3722 | South Korea |
| Asan Medical Center | Seoul | 5505 | South Korea |
| Gangnam Severance Hospital, Yonsei University Health System | Seoul | 6273 | South Korea |
| Samsung Medical Center | Seoul | 6351 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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The safety analysis set (SAS) consisted all enrolled participants who received at least one documented dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vedolizumab | Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Weight | Number analyzed signifies participants for whom body weight data was available at baseline. | Mean | Standard Deviation | kilogram (kg) |
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| Body Mass Index (BMI) | Number analyzed signifies participants for whom BMI was available at baseline. | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| Smoking Status | Count of Participants | Participants |
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| Family History | Count of Participants | Participants |
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| Comorbidities | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The full analysis set (FAS) consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 6 |
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| Primary | Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs) | The SAS consisted all enrolled participants who received at least one documented dose of study medication. | Posted | Number | percentage of participants | 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) |
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| Primary | Percentage of Participants With Pregnancy During the Study | The SAS consisted all enrolled participants who received at least one documented dose of study medication. | Posted | Number | percentage of participants | 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) |
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| Secondary | 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. | The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 14 |
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| Secondary | 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. | The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, n (number analyzed) signifies number of participants who were analyzed at specified time point. | Posted | Number | percentage of participants | Weeks 6 and 14 |
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| Secondary | 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. | The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, n (number analyzed) signifies number of participants who were analyzed at specified time point. | Posted | Number | percentage of participants | Weeks 6 and 14 |
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Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vedolizumab | Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first. | 0 | 105 | 5 | 105 | 16 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Adenoiditis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Cytomegalovirus colitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Cytomegalovirus syndrome | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2018 | Dec 2, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| >=65 years |
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| Never smoked |
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| Unknown |
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| UC- Parent |
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| Autoimmune hepatitis |
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| Rheumatoid arthritis |
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| Participants |
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