Safety and Effectiveness of Vedolizumab IV in Real World Clinical Practice in Taiwan: A Registry-Based Study

Study identification

• EU PAS number:
  EUPAS27544
• Study ID:
  46956
• Official title and acronym:
  Safety and Effectiveness of Vedolizumab IV in Real World Clinical Practice in Taiwan: A Registry-Based Study
• DARWIN EU® study:
  No
• Study countries:
  Taiwan
• Study description:
  This is a prospective longitudinal cohort study of patients with ulcerative colitis (UC) and Crohn’s disease (CD) who receive at least one dose of vedolizumab intravenous (IV) from August 2017 through May 2020. The study will analyze data from the Taiwan Society of Inflammatory Bowel Disease (TSIBD) prospective inflammatory bowel disease (IBD) registry to provide real-world data on the safety and effectiveness of vedolizumab IV in Taiwanese patients. The Registry collects disease baseline information on patient upon first IBD diagnoses and clinical details on each quarterly follow-up visits. For the purpose of this study, patient demographics, clinical characteristics, and treatment history will be collected on the index date (t0) which is the date a patient receives first dose of vedolizumab IV. The Registry is prospectively updated every 3 months by participating IBD clinics with new information on patient’s disease type, locations, and severity, in addition, information is recorded on changes to medications, IBD-related surgeries and hospitalizations, and reasons for vedolizumab discontinuation (when applicable). This study will enroll at least 90 patients. The overall duration to collect data in this study is 2.75 years.
• Study status:
  Finalised

Research institutions and networks

Institutions

Changhua Christian Hospital, Cheng Hsin General Hospital, Chi Mei Medical Center, Yongkang Taiwan, China Medical University Hospital, Chung Shan Medical University Hospital, Chung-Ho Memorial Hospital Taiwan, E-Da Hospital, Far Eastern Memorial Hospital, Hualien Tzu Chi Medical Center Taiwan, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung Veterans General Hospital, Linkou Chang Gung Memorial Hospital Taiwan, Mackay Memorial Hospital, Mennonite Christian Hospital, National Cheng Kung University Hospital Taiwan, National Taiwan University Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Taichung Veterans General Hospital Taiwan, Taipei City Hospital Taiwan, Taipei Veterans General Hospital Taiwan, Tri-Service General Hospital Taiwan

Study timelines

Date when funding contract was signed

Planned:17/11/2016

Actual:17/11/2016

Study start date

Planned:01/08/2017

Actual:01/08/2017

Data analysis start date

Planned:15/06/2020

Actual:17/05/2020

Date of final study report

Planned:26/10/2020

Actual:06/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable