Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease|
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From enrolment until the time the subject exits the study (up to 3 years) ] [ Designated as safety issue: Yes ]
- Percentage of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: From enrolment until the time the subject exits the study (up to 3 years) ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2016|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Experimental: Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, once every 8 weeks until vedolizumab is commercially available. (Per MM approval, dosing regimen may be modified per physician's decision).
Vedolizumab IV infusion
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 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 regiman 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02743806
|Contact: Takeda Study Registration Call Centeremail@example.com|
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|Study Director:||Medical Director Clinical Science||Takeda|