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

Takeda335 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

335

Conditions

Crohn's Disease

Interventions

Vedolizumab (Genetical Recombination)DRUG

Vedolizumab IV infusion

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have moderate or severe active CD 2. Have inadequate response to existing therapies Exclusion Criteria: Patients with any contraindication for vedolizumab

Locations (1)

Takeda Selected Site

Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to Week 54

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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