Comparison of Vedolizumab treatment to Adalimumab dose intensification in Crohn’s disease patients with loss of response or biomarker activity to Adalimumab on first line with therapeutic drug concentration: A randomized, multicentre, controlled VEDIAN trial.

Prior treatment

• Patients receiving enteral nutrition
• Patients receiving total parenteral nutrition (TPN).
• Patient treated with a concomitant immunosuppressive agent at the time of inclusion. The patient may have been treated with an immunosuppressive agent, but this must have been discontinued at least 4 weeks prior to the screening visit.
• Patient treated with an optimized dose of adalimumab
• Patient previously treated with ustekinumab before adalimumab
• Patients on intravenous corticosteroid therapy
• Previous or current use of vedolizumab or ustekinumab for Crohn's disease
• Concomitant use of immunomodulators
• History of human immunodeficiency virus (HIV), immunodeficiency syndrome, central nervous system (CNS) demyelinating disease (including myelitis), neurological symptoms suggestive of demyelinating disease, chronic recurrent infection, active tuberculosis (received or untreated), severe infections such as sepsis and opportunistic infections.

Other illness

• Patient with short small bowel syndrome as determined by investigator
• Patients with exclusive anoperineal Crohn's disease
• Crohn's disease patient with transient or permanent stoma
• History of cancer

Other

• Pregnant woman
• Participation in a therapeutic study
• Patient under legal protection or unable to give consent
• Hemorrhagic rectocolitis or indeterminate colitis
• Primary non-responder to Adalimumab
• Severe relapse defined by CDAI > 330
• Patient with ileoanal pouchitis or ileorectal anastomosis

• Major patient and having given consent to participate in the study
• Patients with Crohn's disease who responded primarily to the originator or biosimilar adalimumab and have lost response to adalimumab (40 mg every two weeks)
• Patient affiliated to or entitled under a social security scheme
• If the subject is receiving oral corticosteroids other than budesonide or beclometasone dipropionate, the dose must be ≤ 20 mg/day of prednisone or its equivalent and have been stable for at least 2 weeks. The use of corticosteroids is prohibited after week 12.