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Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease

Autor: Marek Horynski, Byong Duk Ye, Stefan Schreiber, Adi Lahat, Katalin Farkas, Sunghyun Kim, Jee Hye Suh, Robert Dudkowiak, Aldis Pukitis, Seul Gi Lee, Walter Reinisch, Shomron Ben-Horin, Mi Rim Kim, Beata Gawdis-Wojnarska, Jaroslaw Kierkus, Jaroslaw Leszczyszyn, Maciej Kowalski, Sang Joon Lee

Publikováno v: Gastroenterology. 160:2340-2353

Background & aims This study compared pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) vs intravenous CT-P13 (CT-P13 IV) in patients with i

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::567552f53d04ad1b31887b430adddbf8
https://doi.org/10.1053/j.gastro.2021.02.068

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A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019

Publikováno v: Open forum infectious diseases. 9(8)

Background We evaluated clinical effectiveness of regdanvimab (CT-P59), a severe acute respiratory syndrome coronavirus 2 neutralizing monoclonal antibody, in reducing disease progression and clinical recovery time in patients with mild-to-moderate c

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0f2c70fe57856b67903bcb46c204a57d
https://pubmed.ncbi.nlm.nih.gov/36043180

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Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial

Publikováno v: Rheumatology (Oxford, England)

Objective To assess non-inferiority of s.c. to i.v. CT-P13 in RA. Methods Patients with active RA and inadequate response to MTX participated in this phase I/III double-blind study at 76 sites. Patients received CT-P13 i.v. 3 mg/kg [week (W) 0 and W2

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bc4871ed28ea4b0d6664335b94ef1675
http://europepmc.org/articles/PMC8121438

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Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial in Outpatients With Mild-to-Moderate Coronavirus Disease 2019

Autor: Anca Streinu-Cercel, Oana Săndulescu, Liliana-Lucia Preotescu, Jin Yong Kim, Yeon-Sook Kim, Shinhye Cheon, Young Rock Jang, Sang Joon Lee, Sung Hyun Kim, Ilsung Chang, Jee Hye Suh, Seul Gi Lee, Mi Rim Kim, Da Rae Chung, Han Na Kim, Adrian Streinu-Cercel, Joong Sik Eom

Publikováno v: Open forum infectious diseases. 9(4)

Background Regdanvimab (CT-P59) is a monoclonal antibody with neutralizing activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report on part 1 of a 2-part randomized, placebo-controlled, double-blind study for patients

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ca41f5d49210fa36fdd581c4c34a6438
https://pubmed.ncbi.nlm.nih.gov/35295819

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Efficacy and safety of CT-P59 plus standard of care: a phase 2/3 randomized, double-blind, placebo-controlled trial in outpatients with mild-to-moderate SARS-CoV-2 infection

Autor: Seul Gi Lee, Jee Hye Suh, Anca Streinu-Cercel, Oana Săndulescu, Han Na Kim, Shin Hyea Cheon, Sung-Hyun Kim, Mi Rim Kim, Michael Ison, Sang Joon Lee, Liliana-Lucia Preotescu, Yeon Sook Kim, Da Rae Chung, Jin Yong Kim, Young Rock Jang, Adrian Streinu-Cercel, Joong Sik Eom, Ilsung Chang

CT-P59, a monoclonal antibody with potent neutralizing activity against severe acute respiratory syndrome coronavirus 2, may ameliorate symptoms and prevent hospitalization in outpatients with mild-to-moderate disease. We report findings from part on

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::c506d88c32c9a2541608c751b270ec36
https://doi.org/10.21203/rs.3.rs-296518/v1

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546. Therapeutic Effect of Regdanvimab in Patients with Mild to Moderate COVID-19: Day 28 Results from a Multicentre, Randomised, Controlled Pivotal Trial

Publikováno v: Open Forum Infectious Diseases

Background Regdanvimab is a monoclonal antibody with activity against SARS-CoV-2. A Phase 2/3 study with two parts is currently ongoing and data up to Day 28 of Part 1 is available while the data from 1315 patients enrolled in Part 2 are expected in

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f790ddad15ebb9e7db55d81eb7c2d172
http://europepmc.org/articles/PMC8644524

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Tu1715 – A Novel Formulation of Ct-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 1-Year Result from a Phase I Open-Label Randomized Controlled Trial in Patients with Active Crohn's Disease

Autor: Byong Duk Ye, Byung Ik Jang, Vladimir Borzan, Adi Lahat, Aldis Pukitis, Marina Osipenko, Yuriy Mostovoy, Stefan Schreiber, Walter Reinisch, Sang Joon Lee, Jee Hye Suh, Seul Gi Lee, JoonHo Lee, Shomron Ben-Horin

Publikováno v: Gastroenterology. 156:S-1096

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::23ab024efd08221fc589d5f90e5bdc3e
https://doi.org/10.1016/s0016-5085(19)39701-x

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