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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    300
  • sponsor
    Takeda
Updated on 27 January 2021
Investigator
Takeda Study Registration Call Center
Primary Contact
Takeda Selected Site (1.8 mi away) Contact
vedolizumab

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.

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment Vedolizumab (Genetical Recombination)
Clinical Study IdentifierNCT04002180
SponsorTakeda
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Patients with any contraindication for vedolizumab
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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