Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: Vedolizumab

Registration Number: NCT03824561

Lead Sponsor: Takeda

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1110

Inclusion Criteria

Have moderate or severe active UC
Have inadequate response to existing therapies

Exclusion Criteria

Patients with any contraindication for vedolizumab

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vedolizumab 300 mg	Vedolizumab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced at Least One Adverse Events (AEs)	Up to Week 54	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.
Number of Participants Who Experienced at Least One Adverse Drug Reactions	Up to Week 54	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab	Week 54
Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab	Week 54
Change From Baseline in Complete Mayo Scores	Baseline and Week 54	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.
Change From Baseline in Partial Mayo Scores	Baseline and Week 54	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.
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score	Baseline and Week 54	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.