Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease
Condition: Colitis, Ulcerative; Crohn Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Intervention: Vedolizumab
Intervention description: Vedolizumab IV infusion
Intervention MeSH terms: Vedolizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 331.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      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.
    

Eligibility 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.