A Study of Vedolizumab in Adults in Real-World Practice

Crohn Disease Clinical Trial

Official title:

A Prospective, Multicenter, Single-arm, Observational Study to Evaluate the Safety and Effectiveness of Vedolizumab in Real-World Clinical Practice in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04872491
• Other study ID #: Vedolizumab-5064
• Status: Active, not recruiting
• Start date: October 22, 2021
• Est. completion date: July 5, 2024

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 5, 2024
• Est. primary completion date: July 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Chongqing General Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Guangdong Province Traditional Chinese Medical Hospital	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Provincial Hospital of Chinese Medicine	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Heilongjiang Provincial Hospital (Nanshang )	Harbin	Heilongjiang
China	Huizhou Central People's Hospital	Huizhou	Guangdong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Affiliated Hospital of Jining Medical University	Jining	Shandong
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital of Chinese Medicine	Nanjing	Jiangsu
China	The Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Shanghai East Hospital	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	Shengjing Hospital of China Medical University	Shengyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Shenzhen Hospital of Southern Medical University	Shenzhen	Guangdong
China	Suzhou Municipal Hospital Original Region	Suzhou	Jiangsu
China	Union Hospital, Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei
China	The 2nd Hospital of XiAn Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs)		Up to Week 72
Primary	Percentage of Participants With Serious Adverse Events (SAEs)		Up to Week 72
Primary	Percentage of Participants With Adverse Events of Special Interests (AESIs)		Up to Week 72
Primary	Percentage of Participants With Adverse Drug Reactions (ADRs)		Up to Week 72
Secondary	Percentage of Participants With Ulcerative Colitis (UC) Achieving Clinical Response Based on Partial Mayo Score	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 sub-scores: 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.	Week 14
Secondary	Percentage of Participants With Crohn's Disease (CD) Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)	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.	Week 14
Secondary	Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score	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 sub-scores: 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.	Week 54
Secondary	Percentage of Participants With CD Achieving Clinical Remission Based on HBI	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.	Week 54
Secondary	Percentage of Participants With UC Achieving Endoscopic Remission	Endoscopic remission in UC is defined as mayo endoscopic sub-score <=1. Mayo endoscopic sub-score (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.	Week 54
Secondary	Percentage of Participants With CD Achieving Endoscopic Remission	Endoscopic remission in CD is defined as absence of any ulcers excluding aphthous ulcers.	Week 54

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