A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting

Korábbi kezelés

• Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181]) at any time prior to screening.
• Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.
• Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).
• Received any investigational biologic therapy <= 6 months prior to screening.
• The participant has received an advanced treatment for an approved indication other than CD or UC within 60 days prior to screening.
  • Advanced therapies include tumor necrosis factor (TNF) inhibitors, 12/23 antagonists, janus kinase (JAK) inhibitors, and sphingosine-1-phosphate (S1P) receptor modulators.
• A surgical procedure requiring general anesthesia within 30 days prior to screening or planned or possible major surgery during the study period.
• Participant is not on a stable dose of corticosteroid.

Más betegség

• In the investigator's opinion, the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has a medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients.
• The participant has any evidence of an active infection during screening.
• Ileostomy, colostomy, severe or symptomatic stenosis of the intestine, or short bowel syndrome.
• Participants with any unstable or uncontrolled cardiovascular conditions, moderate to severe heart failure (New York Heart Association Class III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorders that, in the investigator's opinion, would confound the study results or compromise participant safety.
• Participants with active cerebral or meningeal disease, signs or symptoms or a history of progressive multifocal leukoencephalopathy (PML), or any other major neurological disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.

Laborértékek

• Has any of the following laboratory abnormalities during the screening period: (a) hemoglobin <8 grams per deciliter (g/dL); (b) white blood cell (WBC) count <3.0 × 10\^9 per liter (L); (c) lymphocyte count <0.5 × 10\^9/L; (d) platelet count <100 × 10\^9/L or >1200 × 10\^9/L; (e) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3.0 × the upper limit of normal (ULN); or (f) alkaline phosphatase (ALP) >1.5 × ULN. Historical laboratory data may be used for screening if available in the participant's electronic health record (EHR) within 6 weeks before screening.

Életkor

• History of malignancy, except for adequately treated nonmetastatic basal cell skin cancer; adequately treated squamous cell skin cancer that has not recurred for at least 1 year before screening; and adequately treated cervical carcinoma in situ that has not recurred for at least 3 years before screening. Participants with a remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and therapy received; this must be discussed with the sponsor on a case-by-case basis before enrollment.

Egyéb

• Participants who meet any of the following exclusion criteria will be excluded from participation in this study:

• 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).
• Participants must meet the contraception recommendations.
• 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 sub-score 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.