Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]

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 Crohn's disease (CD) 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 CD. 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 300. 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 [Crohn's Disease]

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Vedolizumab (Genetical Recombination)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have moderate or severe active CD 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 (Genetical Recombination) 300 mg, IV infusion, 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 (Genetical Recombination)<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 |
| --- | --- | --- |
| Change from Baseline in Crohn's Disease Activity Index (CDAI) Score | CDAI is scoring system for the assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. | Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy) | 
| Percentage of Participants with CDAI-100 Response | CDAI-100 response is defined as ≥100-point decrease from baseline in the CDAI score. CDAI is scoring system for the assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. | Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy) | 
| Percentage of Participants with CDAI-70 Response | CDAI-70 response is defined as ≥70-point decrease from baseline in the CDAI score. CDAI is scoring system for the assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. | Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy) | 
| Percentage of Participants with Clinical Remission | Clinical remission is defined as CDAI score of ≤150 points. CDAI is scoring system for the assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. | Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy) | 
| 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 (or discontinuation of vedolizumab therapy) | 
| Change from Baseline in White Blood Cell Count |  | Baseline and up to Week 54 | 
| Change from Baseline in Lymphocytes |  | Baseline and up to Week 54 | 
| Change from Baseline in Hemoglobin |  | Baseline and up to Week 54 | 
| Change from Baseline in Hematocrit |  | Baseline and up to Week 54 | 
| Change from Baseline in Albumin |  | Baseline and up to Week 54 | 
| Change from Baseline in C-reactive protein (CRP) |  | Baseline and up to Week 54 |