Crohn’s Disease

Etrolizumab (Beta 7)  

  • Nonresponder or been intolerant to steroids, immunosuppressives or anti-TNF

  • No prior use of Entyvio

  • 2:1 Etro (high and low dose) to placebo

  • Subcutaneous

  • Responders are re-randomized at week 14 to placebo or low dose Etro

  • If nonresponder, can roll over into Open Label for 52 weeks

Gusulkumab (IL23) and Ustekinumab (IL12/23)

  • Naïve or nonresponder to TNF

  • 5:1 drug and placebo

  • Induction (0,4,8) IV then subcut for up to 44 weeks

  • Placebo non-responders receive Ustekinumab  for 24 weeks

PF-06651600 (JAK3)  and  PF-06700841(TYK2)

  • Naïve or non responder to TNF

  • 2:1 drug and placebo. 

  • ORAL

  • After 12 wks, everyone receives drug for 52 weeks total

Ulcerative Colitis

ABI-M201 (Probiotic) with patients on Mesalamine in mild-moderate UC

  • Must show inadequate response to mesalamine >4 weeks

  • Cohort A 1:1  Cohort B 3:1  (20 subjects each cohort)

  • 8 weeks

  • ORAL

 

Pancreas Divisum

  • Randomized trial of ERCP with minor papilla endoscopic sphincterotomy (miES) for treatment of recurrent acute pancreatitis

  • Must have had an acute pancreatitis attack within 24 months plus one other attack prior

 

Surveillance for first-degree relatives of Crohn’s Disease

  • Screening first degree relatives of Crohn’s disease patients using capsule endoscopy

  • Undergo blood test, questionnaires and patent capsule endoscopy

  • Once reviewed, a capsule endoscopy done. If any signs of CD, colonoscopy scheduled.

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