A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.
∙ To be eligible to participate in this study, participants must meet all the following criteria:
• In the investigator's opinion, the participant can understand and comply with protocol requirements.
• The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.
• The participant is 18 to 80 years of age at the time of signing the ICF.
• The participant's immunization is up to date per vedolizumab US prescribing information (USPI).
• If participant is a woman of childbearing potential (WOCBP):
‣ Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab.
⁃ Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab.
⁃ Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.
⁃ Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.
• If participant is a fertile man:
‣ Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab
⁃ Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.
• The participant has a diagnosis of moderate to severely active UC or CD defined by the following:
‣ CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \>=6 (\>=4 if isolated ileal disease) at screening OR
⁃ UC: A complete Mayo score (MS) of 6 to 12 with endoscopy subscore of 2 to 3 at screening
• UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
• Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and/or advanced therapy.