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Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study.
Ye, Byong Duk; Pesegova, Marina; Alexeeva, Olga; Osipenko, Marina; Lahat, Adi; Dorofeyev, Andriy; Fishman, Sigal; Levchenko, Olena; Cheon, Jae Hee; Scribano, Maria Lia; Mateescu, Radu-Bogdan; Lee, Kang-Moon; Eun, Chang Soo; Lee, Sang Joon; Lee, Sung Young; Kim, HoUng; Schreiber, Stefan; Fowler, Heather; Cheung, Raymond; Kim, Young-Ho.
  • Ye BD; University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
  • Pesegova M; Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk, Russia.
  • Alexeeva O; Nizhny Novgorod Regional Clinical Hospital N A Semashko, Nizhny Novgorod, Russia.
  • Osipenko M; Novosibirsk State Medical University, Novosibirsk, Russia.
  • Lahat A; Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Israel; Sackler Faculty of Medicine, Tel Aviv University, Ramat-Gan, Israel.
  • Dorofeyev A; Medical Center LLC Ukrainian German Antiulcer Gastroenterology Center BIK Kyiv, Kyiv, Ukraine.
  • Fishman S; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sackler Faculty of Medicine, Tel Aviv University, Ramat-Gan, Israel.
  • Levchenko O; Munipial Institution Odesa Regional Clinical Hospital, Odesa, Ukraine.
  • Cheon JH; Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
  • Scribano ML; Gastroenterology Unit, Azienda Ospedaliera San Camillo Forlanini, Rome, Italy.
  • Mateescu RB; Gastroenterology Department, Colentina Clinical Hospital, Bucharest, Romania; Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
  • Lee KM; St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, South Korea.
  • Eun CS; Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea.
  • Lee SJ; Celltrion, Incheon, South Korea.
  • Lee SY; Celltrion, Incheon, South Korea.
  • Kim H; Celltrion, Incheon, South Korea.
  • Schreiber S; University-Hospital Schleswig-Holstein, Christian-Albrechts-University, Dep Medicine I, Kiel, Germany.
  • Fowler H; Pfizer, New York, NY, USA.
  • Cheung R; Pfizer, New York, NY, USA.
  • Kim YH; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: bowelkim@gmail.com.
Lancet ; 393(10182): 1699-1707, 2019 04 27.
Article en En | MEDLINE | ID: mdl-30929895

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Fármacos Gastrointestinales / Enfermedad de Crohn / Biosimilares Farmacéuticos / Infliximab / Anticuerpos Monoclonales Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Año: 2019 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Fármacos Gastrointestinales / Enfermedad de Crohn / Biosimilares Farmacéuticos / Infliximab / Anticuerpos Monoclonales Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Año: 2019 Tipo del documento: Article