Health Condition 1: K529- Noninfective gastroenteritis and colitis, unspecified
Conditions
Interventions
Intervention1: Vedolizumab IV: This is an Open label Extended Access program so no comparator is used in this study.
Subjects will receive a 300mg dose of Vedolizumab by IV infusion over approximate
Sponsors
Takeda Development Centre Asia Pvt Limited TDC Asia
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who have successfully completed participation in qualifying Vedolizumab clinical studies and meet the inclusion/exclusion criteria. The number of subjects will be determined based upon the qualifying subjects who have received treatment with Vedolizumab, completed participation in qualifying vedolizumab clinical studies, meet the inclusion/exclusion criteria and agree to enroll in XAP study. Received vedolizumab (excluding comparator or placebo subjects) during participation in a qualifying vedolizumab study. In the opinion of the investigator, the subject is continuing to derive benefit from vedolizumab and continued treatment with vedolizumab is desired because there is no other comparable product available or the subject may be expected to develop worsening of disease if they were to modify treatment. A male subject who is nonsterilized 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 subject of childbearing potential who is sexually active with a nonsterilized 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
Exclusion criteria: For the subjectâ??s particular clinical scenario, vedolizumab is currently available to the subject through commercial channels, including reimbursement. Subject has any clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the subject being in the study. If female, the subject 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 subject intends to donate sperm during the course of this study or for 18 weeks thereafter. Subject 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To monitor ongoing safety in subjects with UC and CD and to provide access to vedolizumab for qualifying subjects 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 subject may be expected to develop worsening of disease if they were to modify treatment.Timepoint: To monitor ongoing safety in subjects with UC and CD and to provide access to vedolizumab for qualifying subjects 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 subject may be expected to develop worsening of disease if they were to modify treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| proposed vedolizumab IV dose (300 mg every 8 weeks) is consistent with pivotal study data. subjects with moderately to severely active CD or UC.Timepoint: vedolizumab IV 300 mg administered as an IV infusion at Weeks 0 and 2 (induction) followed by every 8 weeks or every 4 weeks administration from Week 6 through Week 52 (maintenance) demonstrated statistically significant differences in efficacy compared with placebo for both the induction phase and maintenance phase and demonstrated an acceptable safety profile. | — |
Countries
Australia, Belgium, Bulgaria, Czech Republic, Estonia, Hungary, Iceland, India, Italy, Latvia, Malaysia, New Zealand, Poland, Republic of Korea, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Taiwan, Turkey, Ukraine
Contacts
Public ContactArun Sundriyal
Development India Private Limited
Outcome results
None listed