Crohn’s Disease

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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

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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

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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

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Ulcerative Colitis

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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

 

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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

 

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Surveillance for first-degree relatives of Crohn’s Disease

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• 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.