Effects of vedolizumab in Japanese patients with Crohn’s disease: a prospective, multicenter, randomized, placebo-controlled Phase 3 trial with exploratory analyses

Background Vedolizumab is a gut-selective humanized antibody that binds the α 4 β 7 integrin. We evaluated efficacy and safety of vedolizumab in Japanese patients with moderate-to-severe Crohn’s disease (CD). Methods In this Phase 3, double-blind study (NCT02038920), 157 patients were randomized to...

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Veröffentlicht in:	Journal of gastroenterology 2020-03, Vol.55 (3), p.291-306
Hauptverfasser:	Watanabe, Kenji, Motoya, Satoshi, Ogata, Haruhiko, Kanai, Takanori, Matsui, Toshiyuki, Suzuki, Yasuo, Shikamura, Mitsuhiro, Sugiura, Kenkichi, Oda, Kazunori, Hori, Tetsuharu, Araki, Takahiro, Watanabe, Mamoru, Hibi, Toshifumi
Format:	Artikel
Sprache:	eng
Schlagworte:	Abdominal Surgery Adult Antibodies Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Clinical trials Colorectal Surgery Crohn Disease - drug therapy Crohn Disease - physiopathology Crohn's disease Double-Blind Method Female Gastroenterology Gastrointestinal Agents - administration & dosage Gastrointestinal Agents - adverse effects Hepatology Humans Induction therapy Intravenous administration Japan Male Medical research Medicine Medicine & Public Health Medicine, Experimental Middle Aged Monoclonal antibodies Original Article—Alimentary Tract Original —Alimentary Tract Patients Prospective Studies Remission Severity of Illness Index Statistical analysis Surgical Oncology Treatment Outcome Tumor necrosis factor-α Viral antibodies Young Adult
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