Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]

Study Overview
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Brief Summary
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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.

Detailed Description
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The drug being tested in this survey is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have UC. This survey 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.

Official Title
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Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Vedolizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have moderate or severe active UC Have inadequate response to existing therapies Exclusion Criteria: Patients with any contraindication for vedolizumab
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vedolizumab 300 mg<br>Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care. | Drug: Vedolizumab<br>* Vedolizumab IV infusion<br>* Other names: Entyvio for IV Infusion 300 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who have One or More Adverse Events | Adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to Week 54 | 
| Number of Participants who have One or More Adverse Drug Reactions | AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | Up to Week 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who have a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab |  | After 3 doses of vedolizumab (Week 6 to 14) | 
| Number of Participants who continue the Therapy After 3 Doses of Vedolizumab |  | After 3 doses of vedolizumab (Week 6 to 14) | 
| 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 sub-scores and ranges from 0 to 12, with higher scores indicating more severe disease. | Baseline and after 3 doses of vedolizumab (Week 6 to 14), 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 sub-scores excluding the sigmoidoscopy sub-score and ranges from 0 to 9, with higher scores indicating more severe disease. | Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 | 
| Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | The SIBDQ is an instrument used to assess quality of life 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 will be reported and is ranging from 10 to 70 with a higher score indicates a better health-related quality of life. | Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 | 
| Change from Baseline in Fecal Calprotectin |  | Baseline and multiple time points up to Week 54 |