Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease

Conditions
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Colitis, Ulcerative, Crohn Disease

Intervention / Treatment
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* Drug: Vedolizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received vedolizumab (excluding comparator or placebo participants) during participation in a qualifying vedolizumab study. 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. 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. 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: For the participant's particular clinical scenario, vedolizumab is currently available to the participant through commercial channels, including reimbursement. 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. 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. If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vedolizumab 300 mg<br>Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) that maybe reduced to once every 4 weeks (Q4W) based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years. | Drug: Vedolizumab<br>* Vedolizumab IV infusion<br>* Other names: Kynteles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. A SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is an important medical event. Percentages are rounded off to the nearest decimal point. | From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years) | 
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. AESIs included serious infections (opportunistic infections, such as progressive multifocal leukoencephalopathy [PML]), malignancies, liver injury, infusion-related hypersensitivity reactions, and injection site reactions. Percentages are rounded off to the nearest decimal point. | From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy