Search Results - "Ikeda, Kimitoshi"

Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: 2-Year Interim Results from the Phase 3 Rising Up Study by Katoh, Norito, Ohya, Yukihiro, Murota, Hiroyuki, Ikeda, Masanori, Hu, Xiaofei, Ikeda, Kimitoshi, Liu, John, Sasaki, Takuya, Raymundo, Eliza M., Teixeira, Henrique D., Saeki, Hidehisa

“…Introduction Upadacitinib, an oral, selective Janus kinase inhibitor, is approved in Japan for the treatment of moderate-to-severe atopic dermatitis (AD), a…”
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Growth analysis among adolescents with moderate-to-severe atopic dermatitis receiving upadacitinib in combination with topical corticosteroids in Japan: A case study series from a phase 3, randomized, controlled trial (Rising Up) by Tanaka, Toshiaki, Sasaki, Takuya, Ikeda, Kimitoshi, Liu, Jianzhong, Tenorio, Allan R., Ohya, Yukihiro

“…Treatment options for adolescents with moderate-to-severe atopic dermatitis (AD) are limited. Oral corticosteroid therapies are used to treat children and…”
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Sample size and proportion of Japanese patients in multi-regional trials by Ikeda, Kimitoshi, Bretz, Frank

“…In recent years, multi‐regional trials have received increasing attention by pharmaceutical companies carrying out global drug development programs. In Japan,…”
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Efficacy and safety of indacaterol/glycopyrronium in Japanese patients with COPD: Pooled analysis of SHINE and ARISE by Asai, Kazuhisa, Hirata, Kazuto, Hashimoto, Shu, Fukuchi, Yoshinosuke, Kitawaki, Tetsuji, Ikeda, Kimitoshi, Fogel, Robert, Banerji, Donald

“…Abstract Background To better evaluate the efficacy and safety of the indacaterol/glycopyrronium (IND/GLY) fixed-dose combination versus tiotropium in Japanese…”
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Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials by Quan, Hui, Li, Mingyu, Chen, Joshua, Gallo, Paul, Binkowitz, Bruce, Ibia, Ekapimo, Tanaka, Yoko, Ouyang, Soo Peter, Luo, Xiaolong, Li, Gang, Menjoge, Shailendra, Talerico, Steven, Ikeda, Kimitoshi

“…Multiregional clinical trials (MRCTs) present great opportunities but also challenges to the trial community. To address the challenges and fully realize the…”
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One Year Treatment with Omalizumab Is Effective and Well Tolerated in Japanese Patients with Moderate-to-Severe Persistent Asthma by Ken, Ohta, Yamamoto, Manabu, Sato, Norio, Ikeda, Kimitoshi, Miyamoto, Terumasa

“…We have previously demonstrated that addition of omalizumab to standard therapy improved asthma control by significantly improving lung function and reducing…”
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Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results by Panés, Julián, Colombel, Jean-Frederic, D’Haens, Geert R., Schreiber, Stefan, Panaccione, Remo, Peyrin-Biroulet, Laurent, Loftus, Edward V., Danese, Silvio, Tanida, Satoshi, Okuyama, Yusuke, Louis, Edouard, Armuzzi, Alessandro, Ferrante, Marc, Vogelsang, Harald, Hibi, Toshifumi, Watanabe, Mamoru, Lefebvre, Jessica, Finney-Hayward, Tricia, Sanchez Gonzalez, Yuri, Doan, Thao T., Mostafa, Nael M., Ikeda, Kimitoshi, Xie, Wangang, Huang, Bidan, Petersson, Joel, Kalabic, Jasmina, Robinson, Anne M., Sandborn, William J.

“…SERENE UC (Study of a Novel Approach to Induction and Maintenance Dosing With Adalimumab in Patients With Moderate to Severe Ulcerative Colitis) evaluated the…”
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One Year Treatment with Omalizumab Is Effective and Well Tolerated in Japanese Patients with Moderate-to-Severe Persistent Asthma by Ken Ohta, Manabu Yamamoto, Norio Sato, Kimitoshi Ikeda, Terumasa Miyamoto

“…「ABSTRACT」 Background: We have previously demonstrated that addition of omalizumab to standard therapy improved asthma control by significantly improving lung…”
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Consistency of Treatment Effect across Regions in Multiregional Clinical Trials, Part 1: Design Considerations by Chen, Joshua, Quan, Hui, Gallo, Paul, Menjoge, Shailendra, Luo, Xiaolong, Tanaka, Yoko, Li, Gang, Ouyang, S. Peter, Binkowitz, Bruce, Ibia, Ekopimo, Talerico, Steven, Ikeda, Kimitoshi

“…Assessment of consistency of treatment effect across regions is often a key issue in a multiregional clinical trial (MRCT) because of differences in intrinsic…”
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A phase 3 randomized, multicenter, double-blind study to evaluate the safety of upadacitinib in combination with topical corticosteroids in adolescent and adult patients with moderate-to-severe atopic dermatitis in Japan (Rising Up): An interim 24-week analysis by Katoh, Norito, Ohya, Yukihiro, Murota, Hiroyuki, Ikeda, Masanori, Hu, Xiaofei, Ikeda, Kimitoshi, Liu, John, Sasaki, Takuya, Chu, Alvina D., Teixeira, Henrique D., Saeki, Hidehisa

“…Systemic atopic dermatitis treatments that have acceptable safety are needed. To evaluate the safety of the oral Janus kinase inhibitor upadacitinib in…”
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Consistency of Treatment Effect across Regions in Multiregional Clinical Trials, Part 2: Monitoring, Reporting, and Interpretation by Gallo, Paul, Chen, Joshua, Quan, Hui, Menjoge, Shailendra, Luo, Xiaolong, Tanaka, Yoko, Li, Gang, Ouyang, S. Peter, Binkowitz, Bruce, Ibia, Ekopimo, Talerico, Steven, Ikeda, Kimitoshi

“…The degree of consistency of treatment effects seen across regions within a multiregional clinical trial has important implications for all stakeholders. It…”
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A phase 3 randomized, multicenter, double-blind study to evaluate the safety of upadacitinib in combination with topical corticosteroids in adolescent and adult patients with moderate-to-severe atopic dermatitis in Japan (Rising Up): An interim 24-week analysisCapsule Summary by Norito Katoh, MD, PhD, Yukihiro Ohya, MD, PhD, Hiroyuki Murota, MD, PhD, Masanori Ikeda, MD, PhD, Xiaofei Hu, PhD, Kimitoshi Ikeda, PhD, John Liu, MD, MS, Takuya Sasaki, Alvina D. Chu, MD, Henrique D. Teixeira, PhD, MBA, Hidehisa Saeki, MD, PhD

“…Background: Systemic atopic dermatitis treatments that have acceptable safety are needed. Objective: To evaluate the safety of the oral Janus kinase inhibitor…”
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Efficacy and safety of indacaterol/glycopyrronium in Japanese patients with COPD: a subgroup analysis from the SHINE study by Hashimoto, Shu, Ikeuchi, Hisataro, Murata, Shujiro, Kitawaki, Tetsuji, Ikeda, Kimitoshi, Banerji, Donald

“…COPD-related deaths are increasing in Japan, with ~5.3 million people at risk. The SHINE was a 26-week, multicenter, randomized, double-blind, parallel-group…”
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Efficacy and safety of indacaterol/glycopyrronium in Japanese patients with COPD: a subgroup analysis from the SHINE study [Corrigendum] by Hashimoto, Shu, Ikeuchi, Hisataro, Murata, Shujiro, Kitawaki, Tetsuji, Ikeda, Kimitoshi, Banerji, Donald

“…Hashimoto S, Ikeuchi H, Murata S, Kitawaki T, Ikeda K, Banerji D. Int J Chron Obstruct Pulmon Dis. 2016;11:2543–2551. On page 2547, Figure 5, x-axis, the dose…”
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