A Study of Vedolizumab in Adults in Real-World Practice

Last updated: July 19, 2024
Sponsor: Takeda
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04872491
Vedolizumab-5064
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with UC or CD

  2. Firstly prescribed with vedolizumab

Exclusion

Exclusion Criteria:

  1. Currently enrolled in or plan to participate in any other clinical trials (that is,interventional study)

  2. Contraindicated for vedolizumab according to product package insert

Study Design

Total Participants: 500
Study Start date:
October 22, 2021
Estimated Completion Date:
July 17, 2024

Study Description

This is a non-interventional, prospective study of participants with UC or CD who are prescribed and will start vedolizumab in the real word setting for the first time.

This study will evaluate the safety and effectiveness of vedolizumab in a routine clinical practice setting under real world conditions.

The study will enroll approximately 500 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic data capture (eDC). All participants will be enrolled in a single observational group:

• Participants with UC or CD

This multi-center trial will be conducted in China. The overall duration of the study will be approximately 72 weeks.

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing 102218
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing 100032
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Chongqing General Hospital

    Chongqing, Chongqing 400013
    China

    Site Not Available

  • Guangdong Province Traditional Chinese Medical Hospital

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510655
    China

    Site Not Available

  • Huizhou Central People's Hospital

    Huizhou, Guangdong 516001
    China

    Site Not Available

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong 515041
    China

    Site Not Available

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong 518000
    China

    Site Not Available

  • Heilongjiang Provincial Hospital (Nanshang )

    Harbin, Heilongjiang 150036
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • Xiangya Hospital, Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Suzhou Municipal Hospital Original Region

    Suzhou, Jiangsu 251002
    China

    Site Not Available

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116011
    China

    Site Not Available

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning 116023
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shengyang, Liaoning 110004
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Binzhou Medical University Hospital

    Binzhou, Shandong 256603
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong 272029
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266003
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai, Shanghai 200120
    China

    Site Not Available

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200092
    China

    Site Not Available

  • The 2nd Hospital of XiAn Jiaotong University

    Xi'an, Shanxi 710004
    China

    Site Not Available

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan 646099
    China

    Site Not Available

  • Tianjin Union Medical Center

    Tianjin, Tianjin 300121
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Zhejiang Provincial Hospital of Chinese Medicine

    Hangzhou, Zhejiang 310006
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Ningbo First Hospital

    Ningbo, Zhejiang 315010
    China

    Site Not Available

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