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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03824561
• Other study ID #: Vedolizumab-5033
• Secondary ID: jRCT1080224534
• Status: Active, not recruiting
• Start date: February 1, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1096
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Have moderate or severe active UC

2. Have inadequate response to existing therapies

Exclusion Criteria:

Patients with any contraindication for vedolizumab

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Vedolizumab
Vedolizumab IV infusion

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	Number of Participants who continue the Therapy After 3 Doses of Vedolizumab		After 3 doses of vedolizumab (Week 6 to 14)
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline in Fecal Calprotectin		Baseline and multiple time points up to Week 54

External Links

•   To obtain more information on the study, click here/on this link