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

• Status: Active, not recruiting
• Trial end date: 2022-02-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to monitor ongoing safety in subjects with ulcerative colitis (UC) and Crohn's disease (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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Vedolizumab

Criteria

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.