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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to Week 72
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Up to Week 72
Percentage of Participants With Adverse Events of Special Interests (AESIs)
Time frame: Up to Week 72
Percentage of Participants With Adverse Drug Reactions (ADRs)
Time frame: Up to Week 72
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.
Time frame: Week 14
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.
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
...and 30 more locations
Time frame: Week 14
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.
Time frame: Week 54
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.
Time frame: Week 54
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.
Time frame: Week 54
Percentage of Participants With CD Achieving Endoscopic Remission
Endoscopic remission in CD is defined as absence of any ulcers excluding aphthous ulcers.
Time frame: Week 54