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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04002180
• Other study ID #: Vedolizumab-4021
• Secondary ID: jRCT1080224753
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: October 31, 2025

Study information

• Verified date: June 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• 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 Crohn's disease (CD) 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Have moderate or severe active CD

2. Have inadequate response to existing therapies

Exclusion Criteria:

Patients with any contraindication for vedolizumab

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Vedolizumab (Genetical Recombination)
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	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)
Secondary	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)
Secondary	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)
Secondary	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)
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 (or discontinuation of vedolizumab therapy)
Secondary	Change from Baseline in White Blood Cell Count		Baseline and up to Week 54
Secondary	Change from Baseline in Lymphocytes		Baseline and up to Week 54
Secondary	Change from Baseline in Hemoglobin		Baseline and up to Week 54
Secondary	Change from Baseline in Hematocrit		Baseline and up to Week 54
Secondary	Change from Baseline in Albumin		Baseline and up to Week 54
Secondary	Change from Baseline in C-reactive protein (CRP)		Baseline and up to Week 54

External Links

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