A Study of Vedolizumab in Adults in Real-World Practice
A Prospective, Multicenter, Single-arm, Observational Study to Evaluate the Safety and Effectiveness of Vedolizumab in Real-World Clinical Practice in China
1 other identifier
observational
500
1 country
40
Brief Summary
Vedolizumab is a medicine that is currently prescribed for adults with moderately to severely active ulcerative colitis or Crohn's disease. In this study, adults with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice. The main aim of the study is to check if participants have side effects from vedolizumab. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Typical duration for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2021
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedStudy Start
First participant enrolled
October 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2024
CompletedJuly 22, 2024
July 1, 2024
2.7 years
May 3, 2021
July 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With Adverse Events (AEs)
Up to Week 72
Percentage of Participants With Serious Adverse Events (SAEs)
Up to Week 72
Percentage of Participants With Adverse Events of Special Interests (AESIs)
Up to Week 72
Percentage of Participants With Adverse Drug Reactions (ADRs)
Up to Week 72
Secondary Outcomes (6)
Percentage of Participants With Ulcerative Colitis (UC) Achieving Clinical Response Based on Partial Mayo Score
Week 14
Percentage of Participants With Crohn's Disease (CD) Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)
Week 14
Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score
Week 54
Percentage of Participants With CD Achieving Clinical Remission Based on HBI
Week 54
Percentage of Participants With UC Achieving Endoscopic Remission
Week 54
- +1 more secondary outcomes
Study Arms (1)
Participants With UC or CD
Participants diagnosed with UC or CD who are prescribed and will start treatment with vedolizumab 300 milligram (mg), infusion, intravenously, at Weeks 0, 2, 6, and every 8 weeks thereafter for up to 54 weeks will be observed prospectively for 72 weeks.
Eligibility Criteria
Participants with UC or CD, who have been prescribed and will start vedolizumab in clinical practice will be observed prospectively.
You may qualify if:
- Diagnosed with UC or CD
- Firstly prescribed with vedolizumab
You may not qualify if:
- Currently enrolled in or plan to participate in any other clinical trials (that is, interventional study)
- Contraindicated for vedolizumab according to product package insert
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (40)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400013, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, Guangdong, 510120, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516001, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 518000, China
Heilongjiang Provincial Hospital (Nanshang )
Harbin, Heilongjiang, 150036, China
Xiangya Hospital, Central South University
Changsha, Hu'nan, 410008, China
The Third Xiangya Hospital of Central South University
Changsha, Hu'nan, 410013, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430022, China
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210029, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Suzhou Municipal Hospital Original Region
Suzhou, Jiangsu, 251002, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116023, China
Shengjing Hospital of China Medical University
Shengyang, Liaoning, 110004, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
The 2nd Hospital of XiAn Jiaotong University
Xi'an, Shan'xi, 710004, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256603, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
The First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, 710061, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646099, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000, China
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, 310006, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2021
First Posted
May 4, 2021
Study Start
October 22, 2021
Primary Completion
July 17, 2024
Study Completion
July 17, 2024
Last Updated
July 22, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.