Clinical trial NCT04002180: Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]
Official title: Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease]
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn's Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2019-06-28
Enrollment: 335
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CD patients treated with vedolizumab for IV infusion 300 mg as part of routine medical care

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 Crohn's disease (CD) patients in the routine clinical setting.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Have moderate or severe active CD
2. Have inadequate response to existing therapies

Exclusion Criteria:

Patients with any contraindication for vedolizumab

Primary outcomes:
measure: Number of Participants who have One or More Adverse Events
timeFrame: Up to Week 54
measure: Number of Participants who have One or More Adverse Drug Reactions
timeFrame: Up to Week 54
Secondary outcomes:
measure: Change from Baseline in Crohn's Disease Activity Index (CDAI) Score
timeFrame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
measure: Percentage of Participants with CDAI-100 Response
timeFrame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
measure: Percentage of Participants with CDAI-70 Response
timeFrame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
measure: Percentage of Participants with Clinical Remission
timeFrame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
measure: Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
timeFrame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
measure: Change from Baseline in White Blood Cell Count
timeFrame: Baseline and up to Week 54
measure: Change from Baseline in Lymphocytes
timeFrame: Baseline and up to Week 54
measure: Change from Baseline in Hemoglobin
timeFrame: Baseline and up to Week 54
measure: Change from Baseline in Hematocrit
timeFrame: Baseline and up to Week 54
measure: Change from Baseline in Albumin
timeFrame: Baseline and up to Week 54
measure: Change from Baseline in C-reactive protein (CRP)
timeFrame: Baseline and up to Week 54
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: