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Anti-TL1A Antibody PF-06480605 Safety and Efficacy for Ulcerative Colitis: A Phase 2a Single-Arm Study

Institution:	1. IBD Center, Humanitas Clinical and Research Center-IRCCS, Milan, Italy;3. Humanitas Research Hospital, Department of Biomedical Sciences, Milan Italy;4. University Vita-Salute San Raffaele, Milan, Italy;5. Jill Roberts Center for IBD, Weill Cornell Medicine, Division of Gastroenterology and Hepatology, New York, New York;7. Brigham and Women’s Hospital, Harvard Medical School, Division of Gastroenterology, Boston, Massachusetts;12. Pfizer Inc, Cambridge, Massachusetts;8. Pfizer Inc, New York, New York;9. Pfizer Inc, Andover, Massachusetts

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Keywords:	Monoclonal Antibody Anti-TL1A Ulcerative Colitis Clinical Trial ADA"} {"#name":"keyword" "$":{"id":"kwrd0035"} "$$":[{"#name":"text" "_":"anti-drug antibody CI"} {"#name":"keyword" "$":{"id":"kwrd0045"} "$$":[{"#name":"text" "_":"confidence interval EI"} {"#name":"keyword" "$":{"id":"kwrd0055"} "$$":[{"#name":"text" "_":"endoscopic improvement FAS"} {"#name":"keyword" "$":{"id":"kwrd0065"} "$$":[{"#name":"text" "_":"full analysis set GI"} {"#name":"keyword" "$":{"id":"kwrd0075"} "$$":[{"#name":"text" "_":"Geboes Index hsCRP"} {"#name":"keyword" "$":{"id":"kwrd0085"} "$$":[{"#name":"text" "_":"high-sensitivity C-reactive protein IBD"} {"#name":"keyword" "$":{"id":"kwrd0095"} "$$":[{"#name":"text" "_":"inflammatory bowel disease IL"} {"#name":"keyword" "$":{"id":"kwrd0105"} "$$":[{"#name":"text" "_":"interleukin IV"} {"#name":"keyword" "$":{"id":"kwrd0115"} "$$":[{"#name":"text" "_":"intravenous MLE"} {"#name":"keyword" "$":{"id":"kwrd0125"} "$$":[{"#name":"text" "_":"maximum likelihood estimator NAb"} {"#name":"keyword" "$":{"id":"kwrd0135"} "$$":[{"#name":"text" "_":"neutralizing antibody PK"} {"#name":"keyword" "$":{"id":"kwrd0145"} "$$":[{"#name":"text" "_":"pharmacokinetics PP"} {"#name":"keyword" "$":{"id":"kwrd0155"} "$$":[{"#name":"text" "_":"per protocol Q2W"} {"#name":"keyword" "$":{"id":"kwrd0165"} "$$":[{"#name":"text" "_":"every 2 weeks RHI"} {"#name":"keyword" "$":{"id":"kwrd0175"} "$$":[{"#name":"text" "_":"Robarts Histopathology Index SAE"} {"#name":"keyword" "$":{"id":"kwrd0185"} "$$":[{"#name":"text" "_":"serious adverse event sTL1A"} {"#name":"keyword" "$":{"id":"kwrd0195"} "$$":[{"#name":"text" "_":"total soluble tumor necrosis factor-like ligand 1A (free and drug-bound) TEAE"} {"#name":"keyword" "$":{"id":"kwrd0205"} "$$":[{"#name":"text" "_":"treatment-emergent adverse event Th"} {"#name":"keyword" "$":{"id":"kwrd0215"} "$$":[{"#name":"text" "_":"T helper TL1A"} {"#name":"keyword" "$":{"id":"kwrd0225"} "$$":[{"#name":"text" "_":"tumor necrosis factor-like ligand 1A TNFi"} {"#name":"keyword" "$":{"id":"kwrd0235"} "$$":[{"#name":"text" "_":"tumor necrosis factor inhibitor UC"} {"#name":"keyword" "$":{"id":"kwrd0245"} "$$":[{"#name":"text" "_":"ulcerative colitis UMVUE"} {"#name":"keyword" "$":{"id":"kwrd0255"} "$$":[{"#name":"text" "_":"uniformly minimum-variance unbiased estimator
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