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8 results on '"Molina, Francisco Fidencio Cons"'

1. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial

Author

Morin, Frederic, Rahman, Proton, Ariel, Federico, Berman, Alberto, Carrio, Judith, Lucero, Eleonora, Cocco, Jose Maldonado, Hidalgo, Rodolfo Pardo, Velasco, Jorge, Viola, Diego O., Grisar, Johannes, Resch, Heinrich, Scheinecker, Clemens, Melazzi, Ana Claudia, Roimicher, Luis, Scotton, Antonio Scafuto, Rodriguez, Aaron Alejandro Barrera, Molina, Francisco Fidencio Cons, Barragan, Sergio Duran, Skinner, Cassandra M., Tena, Cesar Francisco Pacheco, Remus, Cesar Ricardo Ramos, Rodriguez, Juan Cruz Rizo, Hong, Seung-Jae, Kang, Seong Wook, Lee, Chang Keun, Lee, Eun Bong, Lee, Sang Heon, Park, Min-Chan, Lee, Sang-Hoon, Dokoupilova, Eva, Dvorak, Zdenek, Malcova, Martina, Pvelka, Karel, Eklund, Kari K., Jarvinen, Pentti, Karjalainen, Anna, Paimela, Leena, Taniguchi, Yoshinori, Tsuda, Tokutaro, Tada, Kurisu, Dobashi, Hiroaki, Inui, Kentaro, Ueki, Yukitaka, Matsumoto, Yoshifuji, Hatta, Kazuhiro, Atsumi, Tatsuya, Goto, Hitoshi, Honjo, Shigeru, Matsui, Kiyoshi, Takakubo, Yuya, Neeck, Gunther, Wagner, Sylke, Braun, Jürgen, Blicharshi, Tomasz, Dudek, Anna, Hrycai, Pawel, Plebanski, Rafal, Drabiszcak-Piatkowska, Janina, Brzezicki, Jan, Krogulec, Marek, Opris-Belinski, Daniela, Ramazan, Ana Maria, Tronaru, Luminita, van de Sande, Marleen G., Matsievskaya, Galina, Schmidt, Evgeniya, Stanislav, Marina, Yakushin, Sergey, Ershova, Olga, Rebroy, Andrey, Churchill, Melvin A., Flint, Kathleen P., Greenwald, Maria, Howell, Mary P., Kaine, Jeffrey L., Kivitz, Alan, Klein, Steven J., Mueller, Eric C., Peters, Eric A., Querubin, Roel, Sayers, Michael E., Scoville, Craig D., Shanahan, Joseph C., Roseff, Richard, Hull, John E., Mallepalli, Jyothi R., Sebai, Mohamed B., Kimmel, Steven C., Goddard, David H., Mease, Philip J., Harris, Mark D., Mabaquiao, Arthur R., Diegel, Roger J., Thai, Christine, Rivera, Tania L., Perez-De Jesus, Amarilis, Soto-Raices, Oscar, Toro-Torres, Ramon, Pantojas, Carlos, Deodhar, Atul, van der Heijde, Désirée, Gensler, Lianne S, Kim, Tae-Hwan, Maksymowych, Walter P, Østergaard, Mikkel, Poddubnyy, Denis, Marzo-Ortega, Helena, Bessette, Louis, Tomita, Tetsuya, Leung, Ann, Hojnik, Maja, Gallo, Gaia, Li, Xiaoqi, Adams, David, Carlier, Hilde, and Sieper, Joachim

Published
2020
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2. Challenges and opportunities for quality densitometry in Latin America

Author

Maeda, Sergio Setsuo, LLibre, Ramiro Da Silva, Arantes, Henrique Pierotti, de Souza, Guilherme Cardenaz, Molina, Francisco Fidencio Cons, Wiluzanski, Diana, Taborda, Jorge Antonio Cedeño, Montaño, Claudia Campusano, Vargas, Tatiana Maida, Lopez, Guillermo Luis Feldmann, Neira, Luis Vidal, Uribe, Gustavo Adolfo Molina, Salica, Daniel, Bencosme, Ascanio Rafael, Perez, Sonia Cerdas, Acosta, Carlos Ramón Rios, Carey, John J., and Borges, João Lindolfo Cunha

Published
2021
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3. Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial

Author

Yoo, Dae Hyun, Suh, Chang-Hee, Shim, Seung Cheol, Jeka, Slawomir, Molina, Francisco Fidencio Cons, Hrycaj, Pawel, Wiland, Piotr, Lee, Eun Young, Medina-Rodriguez, Francisco G., Shesternya, Pavel, Radominski, Sebastiao, Stanislav, Marina, Kovalenko, Volodymyr, Sheen, Dong Hyuk, Myasoutova, Leysan, Lim, Mie Jin, Choe, Jung-Yoon, Lee, Sang Joon, Lee, Sung Young, Kim, Sung Hwan, and Park, Won

Published
2017
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4. Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis

Author

Park, Won, Suh, Chang-Hee, Shim, Seung Cheol, Molina, Francisco Fidencio Cons, Jeka, Slawomir, Medina-Rodriguez, Francisco G., Hrycaj, Pawel, Wiland, Piotr, Lee, Eun Young, Shesternya, Pavel, Kovalenko, Volodymyr, Myasoutova, Leysan, Stanislav, Marina, Radominski, Sebastiao, Lim, Mie Jin, Choe, Jung-Yoon, Lee, Sang Joon, Lee, Sung Young, Kim, Sung Hwan, and Yoo, Dae Hyun

Published
2017
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5. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X):a randomised, placebo-controlled trial

Author

Deodhar, Atul, van der Heijde, Désirée, Gensler, Lianne S., Kim, Tae Hwan, Maksymowych, Walter P., Østergaard, Mikkel, Poddubnyy, Denis, Marzo-Ortega, Helena, Bessette, Louis, Tomita, Tetsuya, Leung, Ann, Hojnik, Maja, Gallo, Gaia, Li, Xiaoqi, Adams, David, Carlier, Hilde, Sieper, Joachim, Morin, Frederic, Rahman, Proton, Ariel, Federico, Berman, Alberto, Carrio, Judith, Lucero, Eleonora, Cocco, Jose Maldonado, Hidalgo, Rodolfo Pardo, Velasco, Jorge, Viola, Diego O., Grisar, Johannes, Resch, Heinrich, Scheinecker, Clemens, Melazzi, Ana Claudia, Roimicher, Luis, Scotton, Antonio Scafuto, Rodriguez, Aaron Alejandro Barrera, Molina, Francisco Fidencio Cons, Barragan, Sergio Duran, Skinner, Cassandra M., Tena, Cesar Francisco Pacheco, Remus, Cesar Ricardo Ramos, Rodriguez, Juan Cruz Rizo, Hong, Seung Jae, Kang, Seong Wook, Lee, Chang Keun, Lee, Eun Bong, Lee, Sang Heon, Park, Min Chan, Lee, Sang Hoon, Dokoupilova, Eva, Dvorak, Zdenek, Malcova, Martina, Deodhar, Atul, van der Heijde, Désirée, Gensler, Lianne S., Kim, Tae Hwan, Maksymowych, Walter P., Østergaard, Mikkel, Poddubnyy, Denis, Marzo-Ortega, Helena, Bessette, Louis, Tomita, Tetsuya, Leung, Ann, Hojnik, Maja, Gallo, Gaia, Li, Xiaoqi, Adams, David, Carlier, Hilde, Sieper, Joachim, Morin, Frederic, Rahman, Proton, Ariel, Federico, Berman, Alberto, Carrio, Judith, Lucero, Eleonora, Cocco, Jose Maldonado, Hidalgo, Rodolfo Pardo, Velasco, Jorge, Viola, Diego O., Grisar, Johannes, Resch, Heinrich, Scheinecker, Clemens, Melazzi, Ana Claudia, Roimicher, Luis, Scotton, Antonio Scafuto, Rodriguez, Aaron Alejandro Barrera, Molina, Francisco Fidencio Cons, Barragan, Sergio Duran, Skinner, Cassandra M., Tena, Cesar Francisco Pacheco, Remus, Cesar Ricardo Ramos, Rodriguez, Juan Cruz Rizo, Hong, Seung Jae, Kang, Seong Wook, Lee, Chang Keun, Lee, Eun Bong, Lee, Sang Heon, Park, Min Chan, Lee, Sang Hoon, Dokoupilova, Eva, Dvorak, Zdenek, and Malcova, Martina

Abstract

Background: Ixekizumab, a high-affinity interleukin-17A (IL-17A) monoclonal antibody, has previously shown efficacy in radiographic axial spondyloarthritis (also known as ankylosing spondylitis). We aimed to evaluate the efficacy and safety of ixekizumab, an IL-17 inhibitor, in non-radiographic axial spondyloarthritis. Here, we report the primary results of COAST-X. Methods: COAST-X was a 52-week, randomised, double-blind, placebo-controlled, parallel-group study done at 107 sites in 15 countries in Europe, Asia, North America, and South America. Eligible participants were adults (aged ≥18 years) with active axial spondyloarthritis without definite radiographic sacroiliitis (non-radiographic axial spondyloarthritis), objective signs of inflammation (via MRI or C-reactive protein), and an inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomly assigned (1:1:1) to receive subcutaneous 80 mg ixekizumab every 4 weeks (Q4W) or every 2 weeks (Q2W), or placebo. Changing background medications or switching to open-label ixekizumab Q2W, or both, was allowed after week 16 at investigator discretion. Primary endpoints were Assessment of SpondyloArthritis international Society-40 (ASAS40) response (defined as an improvement of 40% or more and an absolute improvement from baseline of 2 units or more [range 0–10] in at least three of the four domains [patient global, spinal pain, function, and inflammation] without any worsening in the remaining one domain) at weeks 16 and 52. Patients who switched to open-label ixekizumab were imputed as non-responders in logistic regression analysis. This trial is registered with ClinicalTrials.gov, number NCT02757352. Findings: Between Aug 2, 2016, and Jan 29, 2018, 303 patients were enrolled (105 to placebo, 96 to ixekizumab Q4W, and 102 to ixekizumab Q2W). Both primary endpoints were met: ASAS40 at week 16 (ixekizumab Q4W: 34 [35%] of 96, p=0·0094 vs placebo; ixekizumab Q2W: 41 [40%] of

Published
2020

6. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial

Author

Deodhar, Atul, primary, van der Heijde, Désirée, additional, Gensler, Lianne S, additional, Kim, Tae-Hwan, additional, Maksymowych, Walter P, additional, Østergaard, Mikkel, additional, Poddubnyy, Denis, additional, Marzo-Ortega, Helena, additional, Bessette, Louis, additional, Tomita, Tetsuya, additional, Leung, Ann, additional, Hojnik, Maja, additional, Gallo, Gaia, additional, Li, Xiaoqi, additional, Adams, David, additional, Carlier, Hilde, additional, Sieper, Joachim, additional, Morin, Frederic, additional, Rahman, Proton, additional, Ariel, Federico, additional, Berman, Alberto, additional, Carrio, Judith, additional, Lucero, Eleonora, additional, Cocco, Jose Maldonado, additional, Hidalgo, Rodolfo Pardo, additional, Velasco, Jorge, additional, Viola, Diego O., additional, Grisar, Johannes, additional, Resch, Heinrich, additional, Scheinecker, Clemens, additional, Melazzi, Ana Claudia, additional, Roimicher, Luis, additional, Scotton, Antonio Scafuto, additional, Rodriguez, Aaron Alejandro Barrera, additional, Molina, Francisco Fidencio Cons, additional, Barragan, Sergio Duran, additional, Skinner, Cassandra M., additional, Tena, Cesar Francisco Pacheco, additional, Remus, Cesar Ricardo Ramos, additional, Rodriguez, Juan Cruz Rizo, additional, Hong, Seung-Jae, additional, Kang, Seong Wook, additional, Lee, Chang Keun, additional, Lee, Eun Bong, additional, Lee, Sang Heon, additional, Park, Min-Chan, additional, Lee, Sang-Hoon, additional, Dokoupilova, Eva, additional, Dvorak, Zdenek, additional, Malcova, Martina, additional, Pvelka, Karel, additional, Eklund, Kari K., additional, Jarvinen, Pentti, additional, Karjalainen, Anna, additional, Paimela, Leena, additional, Taniguchi, Yoshinori, additional, Tsuda, Tokutaro, additional, Tada, Kurisu, additional, Dobashi, Hiroaki, additional, Inui, Kentaro, additional, Ueki, Yukitaka, additional, Matsumoto, Yoshifuji, additional, Hatta, Kazuhiro, additional, Atsumi, Tatsuya, additional, Goto, Hitoshi, additional, Honjo, Shigeru, additional, Matsui, Kiyoshi, additional, Takakubo, Yuya, additional, Neeck, Gunther, additional, Wagner, Sylke, additional, Braun, Jürgen, additional, Blicharshi, Tomasz, additional, Dudek, Anna, additional, Hrycai, Pawel, additional, Plebanski, Rafal, additional, Drabiszcak-Piatkowska, Janina, additional, Brzezicki, Jan, additional, Krogulec, Marek, additional, Opris-Belinski, Daniela, additional, Ramazan, Ana Maria, additional, Tronaru, Luminita, additional, van de Sande, Marleen G., additional, Matsievskaya, Galina, additional, Schmidt, Evgeniya, additional, Stanislav, Marina, additional, Yakushin, Sergey, additional, Ershova, Olga, additional, Rebroy, Andrey, additional, Churchill, Melvin A., additional, Flint, Kathleen P., additional, Greenwald, Maria, additional, Howell, Mary P., additional, Kaine, Jeffrey L., additional, Kivitz, Alan, additional, Klein, Steven J., additional, Mueller, Eric C., additional, Peters, Eric A., additional, Querubin, Roel, additional, Sayers, Michael E., additional, Scoville, Craig D., additional, Shanahan, Joseph C., additional, Roseff, Richard, additional, Hull, John E., additional, Mallepalli, Jyothi R., additional, Sebai, Mohamed B., additional, Kimmel, Steven C., additional, Goddard, David H., additional, Mease, Philip J., additional, Harris, Mark D., additional, Mabaquiao, Arthur R., additional, Diegel, Roger J., additional, Thai, Christine, additional, Rivera, Tania L., additional, Perez-De Jesus, Amarilis, additional, Soto-Raices, Oscar, additional, Toro-Torres, Ramon, additional, and Pantojas, Carlos, additional

Published
2020
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7. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial

Author

Park, Won, primary, Božić-Majstorović, Ljubinka, additional, Milakovic, Dragana, additional, Berrocal Kasay, Alfredo, additional, El-Khouri, Elias Chalouhi, additional, Irazoque-Palazuelos, Fedra, additional, Molina, Francisco Fidencio Cons, additional, Shesternya, Pavel, additional, Miranda, Pedro, additional, Medina-Rodriguez, Francisco G., additional, Wiland, Piotr, additional, Jeka, Slawomir, additional, Chavez-Corrales, Jose, additional, Garmish, Olena, additional, Linde, Thomas, additional, Rekalov, Dmytro, additional, Hrycaj, Pawel, additional, Krause, Andreas, additional, Fomina, Natalia, additional, Piura, Olena, additional, Abello-Banfi, Mauricio, additional, Suh, Chang-Hee, additional, Shim, Seung Cheol, additional, Lee, Sang Joon, additional, Lee, Sung Young, additional, Kim, Sung Hwan, additional, and Yoo, Dae Hyun, additional

Published
2018
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8. Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial.

Author

Shim, Seung Cheol, Božić-Majstorović, Ljubinka, Kasay, Alfredo Berrocal, El-Khouri, Elias Chalouhi, Irazoque-Palazuelos, Fedra, Molina, Francisco Fidencio Cons, Medina-Rodriguez, Francisco G, Miranda, Pedro, Shesternya, Pavel, Chavez-Corrales, Jose, Wiland, Piotr, Jeka, Slawomir, Garmish, Olena, Hrycaj, Pawel, Fomina, Natalia, Park, Won, Suh, Chang-Hee, Lee, Sang Joon, Lee, Sung Young, and Bae, Yun Ju

Subjects
ANTIRHEUMATIC agents, IMMUNOGLOBULINS, PATIENT safety, QUALITY of life, RHEUMATOID arthritis, TIME, RITUXIMAB, RANDOMIZED controlled trials, TREATMENT effectiveness, BLIND experiment, BIOSIMILARS, PHARMACODYNAMICS
Abstract

Objective To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA. Methods Patients received 48 weeks' treatment with CT-P10 or United States- or European Union-sourced reference rituximab (US-RTX and EU-RTX, respectively). Patients entering the extension period (weeks 48–72) remained on CT-P10 (CT-P10/CT-P10; n = 122) or US-RTX (US-RTX/US-RTX; n = 64), or switched to CT-P10 from US-RTX (US-RTX/CT-P10; n = 62) or EU-RTX (EU-RTX/CT-P10; n = 47) for an additional course. Efficacy endpoints included Disease Activity Score using 28 joints (DAS28), American College of Rheumatology (ACR) response rates, and quality of life-related parameters. Pharmacodynamics, immunogenicity and safety were also assessed. Results At week 72, similar improvements were observed by disease activity parameters including DAS28 and ACR response rate in the four extension period treatment groups. Quality of life improvements at week 72 vs baseline were similarly shown during the extension period in all groups. Newly developed anti-drug antibodies were detected in two patients following study drug infusion in the extension period. Similar pharmacodynamic and safety profiles were observed across groups. Conclusion Long-term use of CT-P10 up to 72 weeks was effective and well tolerated. Furthermore, switching from reference rituximab to CT-P10 in RA was well tolerated and did not result in any clinically meaningful differences in terms of efficacy, pharmacodynamics, immunogenicity and safety. Trail registration ClinicalTrials.gov, http://clinicaltrials.gov , NCT02149121. [ABSTRACT FROM AUTHOR]

Published
2019
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