The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC) patients in the routine clinical setting.
The drug being tested in this study is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have UC. This study is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical setting. The planned number of observed patients will be approximately 1,000. This multi-center observational trial will be conducted in Japan.
Study Type
OBSERVATIONAL
Enrollment
1,110
Vedolizumab IV infusion
Takeda Selected Site
Tokyo, Japan
Number of Participants Who Experienced at Least One Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Time frame: Up to Week 54
Number of Participants Who Experienced at Least One Adverse Drug Reactions
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. Adverse drug reaction refers to AE related to administered drug.
Time frame: Up to Week 54
Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab
Time frame: Week 54
Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab
Time frame: Week 54
Change From Baseline in Complete Mayo Scores
Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Complete Mayo score sums 4 subscores and ranges from 0 to 12, with higher scores indicating more severe disease.
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Time frame: Baseline and Week 54
Change From Baseline in Partial Mayo Scores
Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Partial Mayo score sums 3 subscores excluding the sigmoidoscopy sub-score and ranges from 0 to 9, with higher scores indicating more severe disease.
Time frame: Baseline and Week 54
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
The SIBDQ is an instrument used to assess quality of life (QOL) and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score is ranging from 10 to 70 with a higher score indicates a better health-related quality of life. Change from Baseline in SIBDQ total score was reported.
Time frame: Baseline and Week 54