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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials</title><author><name sortKey="Felson, David T" sort="Felson, David T" uniqKey="Felson D" first="David T." last="Felson">David T. Felson</name><affiliation><nlm:aff id="A1"> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, USA.</nlm:aff></affiliation><affiliation><nlm:aff id="A34"> Arthritis Research UK Epidemiology Unit, The University of Manchester, UK.</nlm:aff></affiliation></author><author><name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S." last="Smolen">Josef S. Smolen</name><affiliation><nlm:aff id="A2"> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, and 2<sup>nd</sup> Department of Medicine, Center of Rheumatic Diseases, Hietzing Hospital, Vienna, Austria.</nlm:aff></affiliation></author><author><name sortKey="Wells, George" sort="Wells, George" uniqKey="Wells G" first="George" last="Wells">George Wells</name><affiliation><nlm:aff id="A3"> Department of Epidemiology and Community Medicine, University of Ottawa, Canada.</nlm:aff></affiliation></author><author><name sortKey="Zhang, Bin" sort="Zhang, Bin" uniqKey="Zhang B" first="Bin" last="Zhang">Bin Zhang</name><affiliation><nlm:aff id="A1"> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, USA.</nlm:aff></affiliation></author><author><name sortKey="Van Tuyl, Lilian H D" sort="Van Tuyl, Lilian H D" uniqKey="Van Tuyl L" first="Lilian H. D." last="Van Tuyl">Lilian H. D. Van Tuyl</name><affiliation><nlm:aff id="A4"> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam, Netherlands</nlm:aff></affiliation></author><author><name sortKey="Funovits, Julia" sort="Funovits, Julia" uniqKey="Funovits J" first="Julia" last="Funovits">Julia Funovits</name><affiliation><nlm:aff id="A5"> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.</nlm:aff></affiliation></author><author><name sortKey="Aletaha, Daniel" sort="Aletaha, Daniel" uniqKey="Aletaha D" first="Daniel" last="Aletaha">Daniel Aletaha</name><affiliation><nlm:aff id="A5"> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.</nlm:aff></affiliation></author><author><name sortKey="Allaart, Renee" sort="Allaart, Renee" uniqKey="Allaart R" first="Renée" last="Allaart">Renée Allaart</name><affiliation><nlm:aff id="A6"> Leiden University Medical Center, Netherlands.</nlm:aff></affiliation></author><author><name sortKey="Bathon, Joan" sort="Bathon, Joan" uniqKey="Bathon J" first="Joan" last="Bathon">Joan Bathon</name><affiliation><nlm:aff id="A7"> Johns Hopkins University School of Medicine, Baltimore, USA.</nlm:aff></affiliation></author><author><name sortKey="Bombardieri, Stefano" sort="Bombardieri, Stefano" uniqKey="Bombardieri S" first="Stefano" last="Bombardieri">Stefano Bombardieri</name><affiliation><nlm:aff id="A8"> University of Pisa, Italy.</nlm:aff></affiliation></author><author><name sortKey="Brooks, Peter" sort="Brooks, Peter" uniqKey="Brooks P" first="Peter" last="Brooks">Peter Brooks</name><affiliation><nlm:aff id="A9"> University of Melbourne, Melbourne, Australia.</nlm:aff></affiliation></author><author><name sortKey="Brown, Andrew" sort="Brown, Andrew" uniqKey="Brown A" first="Andrew" last="Brown">Andrew Brown</name><affiliation><nlm:aff id="A10"> Hull York Medical School, University of York, UK.</nlm:aff></affiliation></author><author><name sortKey="Matucci Cerinic, Marco" sort="Matucci Cerinic, Marco" uniqKey="Matucci Cerinic M" first="Marco" last="Matucci-Cerinic">Marco Matucci-Cerinic</name><affiliation><nlm:aff id="A11"> University of Florence, Italy.</nlm:aff></affiliation></author><author><name sortKey="Choi, Hyon" sort="Choi, Hyon" uniqKey="Choi H" first="Hyon" last="Choi">Hyon Choi</name><affiliation><nlm:aff id="A1"> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, USA.</nlm:aff></affiliation></author><author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name><affiliation><nlm:aff id="A12"> Division Hopital Lapeyronie, Montpellier University Hospital Montpellier, France.</nlm:aff></affiliation></author><author><name sortKey="De Wit, Maarten" sort="De Wit, Maarten" uniqKey="De Wit M" first="Maarten" last="De Wit">Maarten De Wit</name><affiliation><nlm:aff id="A13"> Department of Medical Humanities, VU University Medical Center, Amsterdam, Netherlands.</nlm:aff></affiliation></author><author><name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name><affiliation><nlm:aff id="A14"> Paris-Descartes University, Medicine Faculty; UPRES-EA ; AP-HP, Cochin Hospital, Rheumatology B Department, Paris, France.</nlm:aff></affiliation></author><author><name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name><affiliation><nlm:aff id="A15"> University of Leeds and Leeds Teaching Hospitals NHS Trust, UK.</nlm:aff></affiliation></author><author><name sortKey="Furst, Dan" sort="Furst, Dan" uniqKey="Furst D" first="Dan" last="Furst">Dan Furst</name><affiliation><nlm:aff id="A16"> David Geffen School of Medicine at the University of California in Los Angeles, USA.</nlm:aff></affiliation></author><author><name sortKey="Gomez Reino, Juan" sort="Gomez Reino, Juan" uniqKey="Gomez Reino J" first="Juan" last="Gomez-Reino">Juan Gomez-Reino</name><affiliation><nlm:aff id="A17"> Hospital Clinico Universitario at the Universidad de Santiago de Compostela, Santiago, Spain.</nlm:aff></affiliation></author><author><name sortKey="Hawker, Gillian" sort="Hawker, Gillian" uniqKey="Hawker G" first="Gillian" last="Hawker">Gillian Hawker</name><affiliation><nlm:aff id="A18"> Women's College Hospital, Toronto, Canada.</nlm:aff></affiliation></author><author><name sortKey="Keystone, Edward" sort="Keystone, Edward" uniqKey="Keystone E" first="Edward" last="Keystone">Edward Keystone</name><affiliation><nlm:aff id="A19"> University of Toronto, Canada.</nlm:aff></affiliation></author><author><name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name><affiliation><nlm:aff id="A16"> David Geffen School of Medicine at the University of California in Los Angeles, USA.</nlm:aff></affiliation></author><author><name sortKey="Kirwan, John" sort="Kirwan, John" uniqKey="Kirwan J" first="John" last="Kirwan">John Kirwan</name><affiliation><nlm:aff id="A20"> University of Bristol, Bristol, UK.</nlm:aff></affiliation></author><author><name sortKey="Kvien, Tore" sort="Kvien, Tore" uniqKey="Kvien T" first="Tore" last="Kvien">Tore Kvien</name><affiliation><nlm:aff id="A21"> Diakonhjemmet Hospital, Oslo, Norway.</nlm:aff></affiliation></author><author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewé">Robert Landewé</name><affiliation><nlm:aff id="A22"> Department of Internal Medicine/Rheumatology, University Hospital Maastricht, Netherlands.</nlm:aff></affiliation></author><author><name sortKey="Listing, Joachim" sort="Listing, Joachim" uniqKey="Listing J" first="Joachim" last="Listing">Joachim Listing</name><affiliation><nlm:aff id="A23"> Deutsches Rheuma-Forschungszentrum, Berlin, Germany.</nlm:aff></affiliation></author><author><name sortKey="Michaud, Kaleb" sort="Michaud, Kaleb" uniqKey="Michaud K" first="Kaleb" last="Michaud">Kaleb Michaud</name><affiliation><nlm:aff id="A24"> University of Nebraska, Omaha, USA.</nlm:aff></affiliation></author><author><name sortKey="Mola, Emilio Martin" sort="Mola, Emilio Martin" uniqKey="Mola E" first="Emilio Martin" last="Mola">Emilio Martin Mola</name><affiliation><nlm:aff id="A25"> Hospital Universitario La Paz, Madrid, Spain.</nlm:aff></affiliation></author><author><name sortKey="Montie, Pam" sort="Montie, Pam" uniqKey="Montie P" first="Pam" last="Montie">Pam Montie</name><affiliation><nlm:aff id="A26"> Arthritis Research Centre of Canada, Vancouver, Canada.</nlm:aff></affiliation></author><author><name sortKey="Pincus, Ted" sort="Pincus, Ted" uniqKey="Pincus T" first="Ted" last="Pincus">Ted Pincus</name><affiliation><nlm:aff id="A27"> New York University School of Medicine, New York, USA.</nlm:aff></affiliation></author><author><name sortKey="Richards, Pam" sort="Richards, Pam" uniqKey="Richards P" first="Pam" last="Richards">Pam Richards</name><affiliation><nlm:aff id="A20"> University of Bristol, Bristol, UK.</nlm:aff></affiliation></author><author><name sortKey="Siegel, Jeff" sort="Siegel, Jeff" uniqKey="Siegel J" first="Jeff" last="Siegel">Jeff Siegel</name><affiliation><nlm:aff id="A28"> Food and Drug Administration, Center for Drug Evaluation and Research, Washington DC, USA.</nlm:aff></affiliation></author><author><name sortKey="Simon, Lee" sort="Simon, Lee" uniqKey="Simon L" first="Lee" last="Simon">Lee Simon</name><affiliation><nlm:aff id="A29"> SDG LLC, Cambridge, USA.</nlm:aff></affiliation></author><author><name sortKey="Sokka, Tuulikki" sort="Sokka, Tuulikki" uniqKey="Sokka T" first="Tuulikki" last="Sokka">Tuulikki Sokka</name><affiliation><nlm:aff id="A30"> Jyväskylä Central Hospital, Jyväskylä, Finland.</nlm:aff></affiliation></author><author><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name><affiliation><nlm:aff id="A31"> Stanford University School of Medicine, Palo Alto, USA.</nlm:aff></affiliation></author><author><name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name><affiliation><nlm:aff id="A32"> University of Ottawa, Canada.</nlm:aff></affiliation></author><author><name sortKey="Tyndall, Alan" sort="Tyndall, Alan" uniqKey="Tyndall A" first="Alan" last="Tyndall">Alan Tyndall</name><affiliation><nlm:aff id="A33"> University of Basel, Switzerland</nlm:aff></affiliation></author><author><name sortKey="Van Der Heijde, Desiree" sort="Van Der Heijde, Desiree" uniqKey="Van Der Heijde D" first="Desirée" last="Van Der Heijde">Desirée Van Der Heijde</name><affiliation><nlm:aff id="A6"> Leiden University Medical Center, Netherlands.</nlm:aff></affiliation></author><author><name sortKey="Verstappen, Suzan" sort="Verstappen, Suzan" uniqKey="Verstappen S" first="Suzan" last="Verstappen">Suzan Verstappen</name><affiliation><nlm:aff id="A34"> Arthritis Research UK Epidemiology Unit, The University of Manchester, UK.</nlm:aff></affiliation></author><author><name sortKey="White, Barbara" sort="White, Barbara" uniqKey="White B" first="Barbara" last="White">Barbara White</name><affiliation><nlm:aff id="A35"> MedImmune, Gaithersburg, USA.</nlm:aff></affiliation></author><author><name sortKey="Wolfe, Fred" sort="Wolfe, Fred" uniqKey="Wolfe F" first="Fred" last="Wolfe">Fred Wolfe</name><affiliation><nlm:aff id="A36"> National Data Bank for Rheumatic Diseases, Wichita, USA.</nlm:aff></affiliation></author><author><name sortKey="Zink, Angela" sort="Zink, Angela" uniqKey="Zink A" first="Angela" last="Zink">Angela Zink</name><affiliation><nlm:aff id="A37"> German Rheumatism Research Center, Berlin, Germany.</nlm:aff></affiliation></author><author><name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name><affiliation><nlm:aff id="A4"> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam, Netherlands</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">21294106</idno><idno type="pmc">3115717</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3115717</idno><idno type="RBID">PMC:3115717</idno><idno type="doi">10.1002/art.30129</idno><date when="2011">2011</date><idno type="wicri:Area/Pmc/Corpus">001403</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001403</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials</title><author><name sortKey="Felson, David T" sort="Felson, David T" uniqKey="Felson D" first="David T." last="Felson">David T. Felson</name><affiliation><nlm:aff id="A1"> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, USA.</nlm:aff></affiliation><affiliation><nlm:aff id="A34"> Arthritis Research UK Epidemiology Unit, The University of Manchester, UK.</nlm:aff></affiliation></author><author><name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S." last="Smolen">Josef S. Smolen</name><affiliation><nlm:aff id="A2"> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, and 2<sup>nd</sup> Department of Medicine, Center of Rheumatic Diseases, Hietzing Hospital, Vienna, Austria.</nlm:aff></affiliation></author><author><name sortKey="Wells, George" sort="Wells, George" uniqKey="Wells G" first="George" last="Wells">George Wells</name><affiliation><nlm:aff id="A3"> Department of Epidemiology and Community Medicine, University of Ottawa, Canada.</nlm:aff></affiliation></author><author><name sortKey="Zhang, Bin" sort="Zhang, Bin" uniqKey="Zhang B" first="Bin" last="Zhang">Bin Zhang</name><affiliation><nlm:aff id="A1"> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, USA.</nlm:aff></affiliation></author><author><name sortKey="Van Tuyl, Lilian H D" sort="Van Tuyl, Lilian H D" uniqKey="Van Tuyl L" first="Lilian H. D." last="Van Tuyl">Lilian H. D. Van Tuyl</name><affiliation><nlm:aff id="A4"> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam, Netherlands</nlm:aff></affiliation></author><author><name sortKey="Funovits, Julia" sort="Funovits, Julia" uniqKey="Funovits J" first="Julia" last="Funovits">Julia Funovits</name><affiliation><nlm:aff id="A5"> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.</nlm:aff></affiliation></author><author><name sortKey="Aletaha, Daniel" sort="Aletaha, Daniel" uniqKey="Aletaha D" first="Daniel" last="Aletaha">Daniel Aletaha</name><affiliation><nlm:aff id="A5"> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.</nlm:aff></affiliation></author><author><name sortKey="Allaart, Renee" sort="Allaart, Renee" uniqKey="Allaart R" first="Renée" last="Allaart">Renée Allaart</name><affiliation><nlm:aff id="A6"> Leiden University Medical Center, Netherlands.</nlm:aff></affiliation></author><author><name sortKey="Bathon, Joan" sort="Bathon, Joan" uniqKey="Bathon J" first="Joan" last="Bathon">Joan Bathon</name><affiliation><nlm:aff id="A7"> Johns Hopkins University School of Medicine, Baltimore, USA.</nlm:aff></affiliation></author><author><name sortKey="Bombardieri, Stefano" sort="Bombardieri, Stefano" uniqKey="Bombardieri S" first="Stefano" last="Bombardieri">Stefano Bombardieri</name><affiliation><nlm:aff id="A8"> University of Pisa, Italy.</nlm:aff></affiliation></author><author><name sortKey="Brooks, Peter" sort="Brooks, Peter" uniqKey="Brooks P" first="Peter" last="Brooks">Peter Brooks</name><affiliation><nlm:aff id="A9"> University of Melbourne, Melbourne, Australia.</nlm:aff></affiliation></author><author><name sortKey="Brown, Andrew" sort="Brown, Andrew" uniqKey="Brown A" first="Andrew" last="Brown">Andrew Brown</name><affiliation><nlm:aff id="A10"> Hull York Medical School, University of York, UK.</nlm:aff></affiliation></author><author><name sortKey="Matucci Cerinic, Marco" sort="Matucci Cerinic, Marco" uniqKey="Matucci Cerinic M" first="Marco" last="Matucci-Cerinic">Marco Matucci-Cerinic</name><affiliation><nlm:aff id="A11"> University of Florence, Italy.</nlm:aff></affiliation></author><author><name sortKey="Choi, Hyon" sort="Choi, Hyon" uniqKey="Choi H" first="Hyon" last="Choi">Hyon Choi</name><affiliation><nlm:aff id="A1"> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, USA.</nlm:aff></affiliation></author><author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name><affiliation><nlm:aff id="A12"> Division Hopital Lapeyronie, Montpellier University Hospital Montpellier, France.</nlm:aff></affiliation></author><author><name sortKey="De Wit, Maarten" sort="De Wit, Maarten" uniqKey="De Wit M" first="Maarten" last="De Wit">Maarten De Wit</name><affiliation><nlm:aff id="A13"> Department of Medical Humanities, VU University Medical Center, Amsterdam, Netherlands.</nlm:aff></affiliation></author><author><name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name><affiliation><nlm:aff id="A14"> Paris-Descartes University, Medicine Faculty; UPRES-EA ; AP-HP, Cochin Hospital, Rheumatology B Department, Paris, France.</nlm:aff></affiliation></author><author><name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name><affiliation><nlm:aff id="A15"> University of Leeds and Leeds Teaching Hospitals NHS Trust, UK.</nlm:aff></affiliation></author><author><name sortKey="Furst, Dan" sort="Furst, Dan" uniqKey="Furst D" first="Dan" last="Furst">Dan Furst</name><affiliation><nlm:aff id="A16"> David Geffen School of Medicine at the University of California in Los Angeles, USA.</nlm:aff></affiliation></author><author><name sortKey="Gomez Reino, Juan" sort="Gomez Reino, Juan" uniqKey="Gomez Reino J" first="Juan" last="Gomez-Reino">Juan Gomez-Reino</name><affiliation><nlm:aff id="A17"> Hospital Clinico Universitario at the Universidad de Santiago de Compostela, Santiago, Spain.</nlm:aff></affiliation></author><author><name sortKey="Hawker, Gillian" sort="Hawker, Gillian" uniqKey="Hawker G" first="Gillian" last="Hawker">Gillian Hawker</name><affiliation><nlm:aff id="A18"> Women's College Hospital, Toronto, Canada.</nlm:aff></affiliation></author><author><name sortKey="Keystone, Edward" sort="Keystone, Edward" uniqKey="Keystone E" first="Edward" last="Keystone">Edward Keystone</name><affiliation><nlm:aff id="A19"> University of Toronto, Canada.</nlm:aff></affiliation></author><author><name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name><affiliation><nlm:aff id="A16"> David Geffen School of Medicine at the University of California in Los Angeles, USA.</nlm:aff></affiliation></author><author><name sortKey="Kirwan, John" sort="Kirwan, John" uniqKey="Kirwan J" first="John" last="Kirwan">John Kirwan</name><affiliation><nlm:aff id="A20"> University of Bristol, Bristol, UK.</nlm:aff></affiliation></author><author><name sortKey="Kvien, Tore" sort="Kvien, Tore" uniqKey="Kvien T" first="Tore" last="Kvien">Tore Kvien</name><affiliation><nlm:aff id="A21"> Diakonhjemmet Hospital, Oslo, Norway.</nlm:aff></affiliation></author><author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewé">Robert Landewé</name><affiliation><nlm:aff id="A22"> Department of Internal Medicine/Rheumatology, University Hospital Maastricht, Netherlands.</nlm:aff></affiliation></author><author><name sortKey="Listing, Joachim" sort="Listing, Joachim" uniqKey="Listing J" first="Joachim" last="Listing">Joachim Listing</name><affiliation><nlm:aff id="A23"> Deutsches Rheuma-Forschungszentrum, Berlin, Germany.</nlm:aff></affiliation></author><author><name sortKey="Michaud, Kaleb" sort="Michaud, Kaleb" uniqKey="Michaud K" first="Kaleb" last="Michaud">Kaleb Michaud</name><affiliation><nlm:aff id="A24"> University of Nebraska, Omaha, USA.</nlm:aff></affiliation></author><author><name sortKey="Mola, Emilio Martin" sort="Mola, Emilio Martin" uniqKey="Mola E" first="Emilio Martin" last="Mola">Emilio Martin Mola</name><affiliation><nlm:aff id="A25"> Hospital Universitario La Paz, Madrid, Spain.</nlm:aff></affiliation></author><author><name sortKey="Montie, Pam" sort="Montie, Pam" uniqKey="Montie P" first="Pam" last="Montie">Pam Montie</name><affiliation><nlm:aff id="A26"> Arthritis Research Centre of Canada, Vancouver, Canada.</nlm:aff></affiliation></author><author><name sortKey="Pincus, Ted" sort="Pincus, Ted" uniqKey="Pincus T" first="Ted" last="Pincus">Ted Pincus</name><affiliation><nlm:aff id="A27"> New York University School of Medicine, New York, USA.</nlm:aff></affiliation></author><author><name sortKey="Richards, Pam" sort="Richards, Pam" uniqKey="Richards P" first="Pam" last="Richards">Pam Richards</name><affiliation><nlm:aff id="A20"> University of Bristol, Bristol, UK.</nlm:aff></affiliation></author><author><name sortKey="Siegel, Jeff" sort="Siegel, Jeff" uniqKey="Siegel J" first="Jeff" last="Siegel">Jeff Siegel</name><affiliation><nlm:aff id="A28"> Food and Drug Administration, Center for Drug Evaluation and Research, Washington DC, USA.</nlm:aff></affiliation></author><author><name sortKey="Simon, Lee" sort="Simon, Lee" uniqKey="Simon L" first="Lee" last="Simon">Lee Simon</name><affiliation><nlm:aff id="A29"> SDG LLC, Cambridge, USA.</nlm:aff></affiliation></author><author><name sortKey="Sokka, Tuulikki" sort="Sokka, Tuulikki" uniqKey="Sokka T" first="Tuulikki" last="Sokka">Tuulikki Sokka</name><affiliation><nlm:aff id="A30"> Jyväskylä Central Hospital, Jyväskylä, Finland.</nlm:aff></affiliation></author><author><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name><affiliation><nlm:aff id="A31"> Stanford University School of Medicine, Palo Alto, USA.</nlm:aff></affiliation></author><author><name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name><affiliation><nlm:aff id="A32"> University of Ottawa, Canada.</nlm:aff></affiliation></author><author><name sortKey="Tyndall, Alan" sort="Tyndall, Alan" uniqKey="Tyndall A" first="Alan" last="Tyndall">Alan Tyndall</name><affiliation><nlm:aff id="A33"> University of Basel, Switzerland</nlm:aff></affiliation></author><author><name sortKey="Van Der Heijde, Desiree" sort="Van Der Heijde, Desiree" uniqKey="Van Der Heijde D" first="Desirée" last="Van Der Heijde">Desirée Van Der Heijde</name><affiliation><nlm:aff id="A6"> Leiden University Medical Center, Netherlands.</nlm:aff></affiliation></author><author><name sortKey="Verstappen, Suzan" sort="Verstappen, Suzan" uniqKey="Verstappen S" first="Suzan" last="Verstappen">Suzan Verstappen</name><affiliation><nlm:aff id="A34"> Arthritis Research UK Epidemiology Unit, The University of Manchester, UK.</nlm:aff></affiliation></author><author><name sortKey="White, Barbara" sort="White, Barbara" uniqKey="White B" first="Barbara" last="White">Barbara White</name><affiliation><nlm:aff id="A35"> MedImmune, Gaithersburg, USA.</nlm:aff></affiliation></author><author><name sortKey="Wolfe, Fred" sort="Wolfe, Fred" uniqKey="Wolfe F" first="Fred" last="Wolfe">Fred Wolfe</name><affiliation><nlm:aff id="A36"> National Data Bank for Rheumatic Diseases, Wichita, USA.</nlm:aff></affiliation></author><author><name sortKey="Zink, Angela" sort="Zink, Angela" uniqKey="Zink A" first="Angela" last="Zink">Angela Zink</name><affiliation><nlm:aff id="A37"> German Rheumatism Research Center, Berlin, Germany.</nlm:aff></affiliation></author><author><name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name><affiliation><nlm:aff id="A4"> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam, Netherlands</nlm:aff></affiliation></author></analytic><series><title level="j">Arthritis and rheumatism</title><idno type="ISSN">0004-3591</idno><idno type="eISSN">1529-0131</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P2">With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials.</p></sec><sec sec-type="methods" id="S2"><title>Methods</title><p id="P3">A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient reported outcomes and the ability of candidate measures to predict later good x-ray and functional outcomes.</p></sec><sec id="S3"><title>Results</title><p id="P4">Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the following measures are all <underline><</underline>1: tender joint count, swollen joint count, CRP (in mg/dL) and patient global assessment (0-10 scale), OR 2: when their score on the SDAI is <underline><</underline> 3.3.</p></sec><sec id="S4"><title>Conclusion</title><p id="P5">We propose two new definitions of remission both of which can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be selected in each trial as an outcome and that the results on both be reported in each trial.</p></sec></div></front></TEI><pmc article-type="research-article" xml:lang="EN"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
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<front><journal-meta><journal-id journal-id-type="nlm-journal-id">0370605</journal-id><journal-id journal-id-type="pubmed-jr-id">881</journal-id><journal-id journal-id-type="nlm-ta">Arthritis Rheum</journal-id><journal-title>Arthritis and rheumatism</journal-title><issn pub-type="ppub">0004-3591</issn><issn pub-type="epub">1529-0131</issn></journal-meta><article-meta><article-id pub-id-type="pmid">21294106</article-id><article-id pub-id-type="pmc">3115717</article-id><article-id pub-id-type="doi">10.1002/art.30129</article-id><article-id pub-id-type="manuscript">NIHMS248972</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Felson</surname><given-names>David T.</given-names></name><xref ref-type="aff" rid="A1">1</xref><xref ref-type="aff" rid="A34">34</xref><xref ref-type="author-notes" rid="FN1">*</xref></contrib><contrib contrib-type="author"><name><surname>Smolen</surname><given-names>Josef S.</given-names></name><xref ref-type="aff" rid="A2">2</xref><xref ref-type="author-notes" rid="FN1">*</xref></contrib><contrib contrib-type="author"><name><surname>Wells</surname><given-names>George</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Zhang</surname><given-names>Bin</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>van Tuyl</surname><given-names>Lilian H. D.</given-names></name><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Funovits</surname><given-names>Julia</given-names></name><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Aletaha</surname><given-names>Daniel</given-names></name><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Allaart</surname><given-names>Renée</given-names></name><xref ref-type="aff" rid="A6">6</xref></contrib><contrib contrib-type="author"><name><surname>Bathon</surname><given-names>Joan</given-names></name><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Bombardieri</surname><given-names>Stefano</given-names></name><xref ref-type="aff" rid="A8">8</xref></contrib><contrib contrib-type="author"><name><surname>Brooks</surname><given-names>Peter</given-names></name><xref ref-type="aff" rid="A9">9</xref></contrib><contrib contrib-type="author"><name><surname>Brown</surname><given-names>Andrew</given-names></name><xref ref-type="aff" rid="A10">10</xref></contrib><contrib contrib-type="author"><name><surname>Matucci-Cerinic</surname><given-names>Marco</given-names></name><xref ref-type="aff" rid="A11">11</xref></contrib><contrib contrib-type="author"><name><surname>Choi</surname><given-names>Hyon</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Combe</surname><given-names>Bernard</given-names></name><xref ref-type="aff" rid="A12">12</xref></contrib><contrib contrib-type="author"><name><surname>de Wit</surname><given-names>Maarten</given-names></name><xref ref-type="aff" rid="A13">13</xref></contrib><contrib contrib-type="author"><name><surname>Dougados</surname><given-names>Maxime</given-names></name><xref ref-type="aff" rid="A14">14</xref></contrib><contrib contrib-type="author"><name><surname>Emery</surname><given-names>Paul</given-names></name><xref ref-type="aff" rid="A15">15</xref></contrib><contrib contrib-type="author"><name><surname>Furst</surname><given-names>Dan</given-names></name><xref ref-type="aff" rid="A16">16</xref></contrib><contrib contrib-type="author"><name><surname>Gomez-Reino</surname><given-names>Juan</given-names></name><xref ref-type="aff" rid="A17">17</xref></contrib><contrib contrib-type="author"><name><surname>Hawker </surname><given-names>Gillian</given-names></name><xref ref-type="aff" rid="A18">18</xref></contrib><contrib contrib-type="author"><name><surname>Keystone</surname><given-names>Edward</given-names></name><xref ref-type="aff" rid="A19">19</xref></contrib><contrib contrib-type="author"><name><surname>Khanna</surname><given-names>Dinesh</given-names></name><xref ref-type="aff" rid="A16">16</xref></contrib><contrib contrib-type="author"><name><surname>Kirwan</surname><given-names>John</given-names></name><xref ref-type="aff" rid="A20">20</xref></contrib><contrib contrib-type="author"><name><surname>Kvien</surname><given-names>Tore</given-names></name><xref ref-type="aff" rid="A21">21</xref></contrib><contrib contrib-type="author"><name><surname>Landewé</surname><given-names>Robert</given-names></name><xref ref-type="aff" rid="A22">22</xref></contrib><contrib contrib-type="author"><name><surname>Listing</surname><given-names>Joachim</given-names></name><xref ref-type="aff" rid="A23">23</xref></contrib><contrib contrib-type="author"><name><surname>Michaud</surname><given-names>Kaleb</given-names></name><xref ref-type="aff" rid="A24">24</xref></contrib><contrib contrib-type="author"><name><surname>Mola</surname><given-names>Emilio Martin</given-names></name><xref ref-type="aff" rid="A25">25</xref></contrib><contrib contrib-type="author"><name><surname>Montie</surname><given-names>Pam</given-names></name><xref ref-type="aff" rid="A26">26</xref></contrib><contrib contrib-type="author"><name><surname>Pincus</surname><given-names>Ted</given-names></name><xref ref-type="aff" rid="A27">27</xref></contrib><contrib contrib-type="author"><name><surname>Richards</surname><given-names>Pam</given-names></name><xref ref-type="aff" rid="A20">20</xref></contrib><contrib contrib-type="author"><name><surname>Siegel</surname><given-names>Jeff</given-names></name><xref ref-type="aff" rid="A28">28</xref></contrib><contrib contrib-type="author"><name><surname>Simon</surname><given-names>Lee</given-names></name><xref ref-type="aff" rid="A29">29</xref></contrib><contrib contrib-type="author"><name><surname>Sokka</surname><given-names>Tuulikki</given-names></name><xref ref-type="aff" rid="A30">30</xref></contrib><contrib contrib-type="author"><name><surname>Strand</surname><given-names>Vibeke</given-names></name><xref ref-type="aff" rid="A31">31</xref></contrib><contrib contrib-type="author"><name><surname>Tugwell</surname><given-names>Peter</given-names></name><xref ref-type="aff" rid="A32">32</xref></contrib><contrib contrib-type="author"><name><surname>Tyndall</surname><given-names>Alan</given-names></name><xref ref-type="aff" rid="A33">33</xref></contrib><contrib contrib-type="author"><name><surname>van der Heijde</surname><given-names>Desirée</given-names></name><xref ref-type="aff" rid="A6">6</xref></contrib><contrib contrib-type="author"><name><surname>Verstappen</surname><given-names>Suzan</given-names></name><xref ref-type="aff" rid="A34">34</xref></contrib><contrib contrib-type="author"><name><surname>White</surname><given-names>Barbara</given-names></name><xref ref-type="aff" rid="A35">35</xref></contrib><contrib contrib-type="author"><name><surname>Wolfe</surname><given-names>Fred</given-names></name><xref ref-type="aff" rid="A36">36</xref></contrib><contrib contrib-type="author"><name><surname>Zink</surname><given-names>Angela</given-names></name><xref ref-type="aff" rid="A37">37</xref></contrib><contrib contrib-type="author"><name><surname>Boers</surname><given-names>Maarten</given-names></name><xref ref-type="aff" rid="A4">4</xref></contrib></contrib-group><aff id="A1"><label>1</label> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, USA.</aff><aff id="A2"><label>2</label> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, and 2<sup>nd</sup> Department of Medicine, Center of Rheumatic Diseases, Hietzing Hospital, Vienna, Austria.</aff><aff id="A3"><label>3</label> Department of Epidemiology and Community Medicine, University of Ottawa, Canada.</aff><aff id="A4"><label>4</label> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam, Netherlands</aff><aff id="A5"><label>5</label> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.</aff><aff id="A6"><label>6</label> Leiden University Medical Center, Netherlands.</aff><aff id="A7"><label>7</label> Johns Hopkins University School of Medicine, Baltimore, USA.</aff><aff id="A8"><label>8</label> University of Pisa, Italy.</aff><aff id="A9"><label>9</label> University of Melbourne, Melbourne, Australia.</aff><aff id="A10"><label>10</label> Hull York Medical School, University of York, UK.</aff><aff id="A11"><label>11</label> University of Florence, Italy.</aff><aff id="A12"><label>12</label> Division Hopital Lapeyronie, Montpellier University Hospital Montpellier, France.</aff><aff id="A13"><label>13</label> Department of Medical Humanities, VU University Medical Center, Amsterdam, Netherlands.</aff><aff id="A14"><label>14</label> Paris-Descartes University, Medicine Faculty; UPRES-EA ; AP-HP, Cochin Hospital, Rheumatology B Department, Paris, France.</aff><aff id="A15"><label>15</label> University of Leeds and Leeds Teaching Hospitals NHS Trust, UK.</aff><aff id="A16"><label>16</label> David Geffen School of Medicine at the University of California in Los Angeles, USA.</aff><aff id="A17"><label>17</label> Hospital Clinico Universitario at the Universidad de Santiago de Compostela, Santiago, Spain.</aff><aff id="A18"><label>18</label> Women's College Hospital, Toronto, Canada.</aff><aff id="A19"><label>19</label> University of Toronto, Canada.</aff><aff id="A20"><label>20</label> University of Bristol, Bristol, UK.</aff><aff id="A21"><label>21</label> Diakonhjemmet Hospital, Oslo, Norway.</aff><aff id="A22"><label>22</label> Department of Internal Medicine/Rheumatology, University Hospital Maastricht, Netherlands.</aff><aff id="A23"><label>23</label> Deutsches Rheuma-Forschungszentrum, Berlin, Germany.</aff><aff id="A24"><label>24</label> University of Nebraska, Omaha, USA.</aff><aff id="A25"><label>25</label> Hospital Universitario La Paz, Madrid, Spain.</aff><aff id="A26"><label>26</label> Arthritis Research Centre of Canada, Vancouver, Canada.</aff><aff id="A27"><label>27</label> New York University School of Medicine, New York, USA.</aff><aff id="A28"><label>28</label> Food and Drug Administration, Center for Drug Evaluation and Research, Washington DC, USA.</aff><aff id="A29"><label>29</label> SDG LLC, Cambridge, USA.</aff><aff id="A30"><label>30</label> Jyväskylä Central Hospital, Jyväskylä, Finland.</aff><aff id="A31"><label>31</label> Stanford University School of Medicine, Palo Alto, USA.</aff><aff id="A32"><label>32</label> University of Ottawa, Canada.</aff><aff id="A33"><label>33</label> University of Basel, Switzerland</aff><aff id="A34"><label>34</label> Arthritis Research UK Epidemiology Unit, The University of Manchester, UK.</aff><aff id="A35"><label>35</label> MedImmune, Gaithersburg, USA.</aff><aff id="A36"><label>36</label> National Data Bank for Rheumatic Diseases, Wichita, USA.</aff><aff id="A37"><label>37</label> German Rheumatism Research Center, Berlin, Germany.</aff><author-notes><corresp id="CR1">Corresponding author: Maarten Boers, MSc, MD, PhD Professor of Clinical Epidemiology Department of Epidemiology and Biostatistics VU University Medical Center, PK 6Z 165 PO Box 7057 1007 MB Amsterdam, Netherlands ph: +3120 444 4474 fx: +3120 444 4475 <email>mboers56@xs4all.nl</email></corresp><fn fn-type="equal" id="FN1"><label>*</label><p id="P1">These two authors contributed equally to this work.</p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>22</day><month>11</month><year>2010</year></pub-date><pub-date pub-type="ppub"><month>3</month><year>2011</year></pub-date><pub-date pub-type="pmc-release"><day>1</day><month>3</month><year>2012</year></pub-date><volume>63</volume><issue>3</issue><fpage>573</fpage><lpage>586</lpage><abstract><sec id="S1"><title>Background</title><p id="P2">With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials.</p></sec><sec sec-type="methods" id="S2"><title>Methods</title><p id="P3">A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient reported outcomes and the ability of candidate measures to predict later good x-ray and functional outcomes.</p></sec><sec id="S3"><title>Results</title><p id="P4">Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the following measures are all <underline><</underline>1: tender joint count, swollen joint count, CRP (in mg/dL) and patient global assessment (0-10 scale), OR 2: when their score on the SDAI is <underline><</underline> 3.3.</p></sec><sec id="S4"><title>Conclusion</title><p id="P5">We propose two new definitions of remission both of which can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be selected in each trial as an outcome and that the results on both be reported in each trial.</p></sec></abstract><contract-num rid="AR1">P60 AR047785-10
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