A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial.

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Title: A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial.
Authors: Cutolo M; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd. mcutolo@unige.it., Myerson GE; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd., Fleischmann RM; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd., Lioté F; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd., Díaz-González F; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd., Van den Bosch F; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd., Marzo-Ortega H; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd., Feist E; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd., Shah K; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd., Hu C; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd., Stevens RM; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd., Poder A; From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd.
Source: The Journal of rheumatology [J Rheumatol] 2016 Sep; Vol. 43 (9), pp. 1724-34. Date of Electronic Publication: 2016 Jul 15.
Publication Type: Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Journal Of Rheumatology Publishing Co Country of Publication: Canada NLM ID: 7501984 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1499-2752 (Electronic) Linking ISSN: 0315162X NLM ISO Abbreviation: J Rheumatol Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1499-2752
DOI:10.3899/jrheum.151376