Testing Vedolizumab for moderately to severely active Crohn's disease

Exclusion

• −Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;
• −Known HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, retesting is not required;
• −Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;
• −Previously exposed to 2 or more compounds or classes of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD;
• −Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of \>40 mg of prednisone or equivalent at randomization;
• −Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;
• −Have a CD complication, such as symptomatic strictures in the small bowel with \>3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;
• −Previous extensive colonic resection or missing \>2 segments out of 5 (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, or a proctocolectomy;
• −Ostomy or ileoanal pouch;
• −Short bowel syndrome;
• −Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgment), including any impassable stenosis;
• −Abscess \>2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;
• −Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study or would compromise participant safety;
• −Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);
• −Known active or latent tuberculosis (TB); if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of careStandard of careThe treatment normally given for a condition outside a study.Read more →) is not required before randomization;
• −Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;
• −Has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;
• −Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.
• −Unwillingness to withhold protocolProtocolThe detailed plan a study must follow.Read more →-prohibited medications during the trial;
• −Concurrent or previous participation in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → and received any investigational therapy within 30 days prior to randomization;
• −History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures;
• −Prior enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in the current study and had received study treatment;
• −Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination with a live or live-attenuated vaccine during participation in the study;
• −Any person performing mandatory military service, deprived of liberty, in a residential care setting, or any person who, due to a judicial decision, cannot take part in clinical studies;
• −The person is an immediate family member, study siteTrial siteA hospital or clinic where a study is actually run.Read more → employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling).
• −Pregnant, lactating, or intending to become pregnant/impregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period;