Clincosm LogoSign in Get a demo

A Study of Vedolizumab in Adults in Real-World Practice

Sponsor
Takeda (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04872491
Collaborator
(none)
750
Enrollment
42
Locations
31.3
Anticipated Duration (Months)
17.9
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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 750 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective, Multicenter, Single-arm, Observational Study to Evaluate the Safety and Effectiveness of Vedolizumab in Real-World Clinical Practice in China
    Actual Study Start Date :
    Oct 22, 2021
    Anticipated Primary Completion Date :
    May 31, 2024
    Anticipated Study Completion Date :
    May 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Adverse Events (AEs) [Up to Week 72]

    2. Percentage of Participants With Serious Adverse Events (SAEs) [Up to Week 72]

    3. Percentage of Participants With Adverse Events of Special Interests (AESIs) [Up to Week 72]

    4. Percentage of Participants With Adverse Drug Reactions (ADRs) [Up to Week 72]

    Secondary Outcome Measures

    1. Percentage of Participants With Ulcerative Colitis (UC) Achieving Clinical Response Based on Partial Mayo Score [Week 14]

      Clinical response in UC is defined as greater than or equal to (>=) 2 points reduction in partial mayo clinic score and >=25 percent (%) decrease from baseline score accompanied with >=1 point decrease in rectal bleeding sub-score or absolute rectal bleeding sub-score less than or equal to (<=) 1 point. Partial mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, 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; where higher scores indicating more severe disease.

    2. Percentage of Participants With Crohn's Disease (CD) Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI) [Week 14]

      Clinical response in CD is defined as >=3-point decrease in the HBI score. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0 equal to [=] very well to 4 = terrible), abdominal pain (0 = none to 3 = severe), number of liquid or soft stools per day, abdominal mass (0 = none to 3 = definite and tender), and complications (8 items; 1 score per item). The total score is sum of sub scores, where score less than (<) 5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and greater than (>) 16 = severe disease activity.

    3. Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score [Week 54]

      Clinical remission in UC is defined as partial mayo clinic score <=2 with no sub-score >1. Partial mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, 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; where higher scores indicating more severe disease.

    4. Percentage of Participants With CD Achieving Clinical Remission Based on HBI [Week 54]

      Clinical remission in CD is defined as HBI score of <=4 points. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0 = very well to 4 = terrible), abdominal pain (0 = none to 3 = severe), number of liquid or soft stools per day, abdominal mass (0 = none to 3 = definite and tender), and complications (8 items; 1 score per item). The total score is sum of sub scores, where score <5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and >16 = severe disease activity.

    5. Percentage of Participants With UC Achieving Endoscopic Remission [Week 54]

      Endoscopic remission in UC is defined as mayo endoscopic sub-score <=1. Mayo endoscopic subscore (findings on endoscopy), each graded from 0 to 3 where 0 = Normal mucosa or inactive disease, 1 = Mild activity (erythema, decreased vascular pattern, mild friability), 2 = Moderate activity (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe activity (spontaneous bleeding, large ulcerations). Higher scores indicating more severe disease.

    6. Percentage of Participants With CD Achieving Endoscopic Remission [Week 54]

      Endoscopic remission in CD is defined as absence of any ulcers excluding aphthous ulcers.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Diagnosed with UC or CD

    2. Firstly prescribed with vedolizumab

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100032
    2 Peking University First Hospital Beijing Beijing China 100034
    3 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China 100050
    4 Peking University Third Hospital Beijing Beijing China 100191
    5 Beijing Tsinghua Changgung Hospital Beijing Beijing China 102218
    6 Chongqing General Hospital Chongqing Chongqing China 400013
    7 The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong China 510080
    8 Guangdong Province Traditional Chinese Medical Hospital Guangzhou Guangdong China 510120
    9 Huizhou Central People's Hospital Huizhou Guangdong China 516002
    10 The First Affiliated Hospital of Shantou University Medical College Shantou Guangdong China 515041
    11 Shenzhen Hospital of Southern Medical University Shenzhen Guangdong China 518000
    12 Heilongjiang Provincial Hospital (Nanshang ) Harbin Heilongjiang China 150036
    13 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
    14 Union Hospital, Tongji Medical College of Huazhong University of Science & Technology Wuhan Hubei China 430022
    15 Xiangya Hospital, Central South University Changsha Hunan China 410008
    16 The 2nd Xiangya Hospital of Central South University Changsha Hunan China 410011
    17 The Third Xiangya Hospital of Central South University Changsha Hunan China 410013
    18 The Affiliated Drum Tower Hospital of Nanjing University Nanjing Jiangsu China 210000
    19 Jiangsu Province Hospital of Chinese Medicine Nanjing Jiangsu China 210029
    20 Jiangsu Province Hospital Nanjing Jiangsu China 210029
    21 Suzhou Municipal Hospital Original Region Suzhou Jiangsu China 215002
    22 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China 116011
    23 The Second Hospital of Dalian Medical University Dalian Liaoning China 116023
    24 Shengjing Hospital of China Medical University Shengyang Liaoning China 110004
    25 The First Hospital of China Medical University Shenyang Liaoning China 110001
    26 Binzhou Medical University Hospital Binzhou Shandong China 256603
    27 Qilu Hospital of Shandong University Jinan Shandong China 250012
    28 Shandong Provincial Hospital Jinan Shandong China 250021
    29 Affiliated Hospital of Jining Medical University Jining Shandong China 272000
    30 The Affiliated Hospital of Qingdao University Qingdao Shandong China 266003
    31 Ruijin Hospital, Shanghai Jiaotong Uni. School of Med. Shanghai Shanghai China 200020
    32 Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200092
    33 Shanghai East Hospital Shanghai Shanghai China 200120
    34 The 2nd Hospital of XiAn Jiaotong University Xi'an Shanxi China 710004
    35 The First Affiliated Hospital of Xian Jiaotong University Xi'an Shanxi China 710061
    36 West China Hospital, Sichuan University Chengdu Sichuan China 610041
    37 The Affiliated Hospital of Southwest Medical University Luzhou Sichuan China 646099
    38 Tianjin Union Medical Center Tianjin Tianjin China 300121
    39 The 2nd Hospital of Tianjin Medical University Tianjin Tianjin China 300211
    40 Zhejiang Provincial People's Hospital Hangzhou Zhejiang China 310000
    41 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
    42 Ningbo First Hospital Ningbo Zhejiang China 315010

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT04872491
    Other Study ID Numbers:
    • Vedolizumab-5064
    First Posted:
    May 4, 2021
    Last Update Posted:
    Nov 29, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Takeda
    Drug Therapy
    Additional relevant MeSH terms:
    Crohn Disease
    Colitis, Ulcerative

    Study Results

    No Results Posted as of Nov 29, 2021