Early Completed - Alternative Source of Drug Available

The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.

The drug being used in this study is called vedolizumab, which is being used to treat people who have ulcerative colitis or Crohn's disease. This study will monitor ongoing safety in the people who take vedolizumab.

Participants who have successfully completed the participation in qualifying vedolizumab clinical studies will be enrolled and assigned to receive:

• Vedolizumab 300 mg

All participants will receive an intravenous (IV) infusion once every 8 weeks until vedolizumab is available through commercial channels, including reimbursement, for the participant's clinical scenario, or until participant withdrawal, whichever comes first. (Per MM approval, dosing regimen may be modified) This multicenter trial will be conducted worldwide. Participants will make multiple visits to the clinic and a final visit at 18 weeks after receiving the last dose of study infusion of vedolizumab for a safety follow-up assessment.

Inclusion Criteria:

1. Received vedolizumab (excluding comparator or placebo participants) during participation in a qualifying vedolizumab study.
2. In the opinion of the investigator, the participant is continuing to derive benefit from vedolizumab and continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.
3. A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
4. A female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.

Exclusion Criteria:

1. For the participant's particular clinical scenario, vedolizumab is currently available to the participant through commercial channels, including reimbursement.
2. Has any clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the participant being in the study.
3. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period.
4. If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter.
5. Has received a live vaccine in the last 18 weeks or is in need of a live vaccine during the study or up to 18 weeks after the last study dose.

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.