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American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials

Identifieur interne : 004114 ( PascalFrancis/Curation ); précédent : 004113; suivant : 004115

American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials

Auteurs : David T. Felson [Italie] ; Josef S. Smolen [Royaume-Uni, Autriche] ; George Wells [Canada] ; BIN ZHANG [États-Unis] ; Lilian H. D. Van Tuyl [Pays-Bas] ; Julia Funovits [Autriche] ; Daniel Aletaha [Autriche] ; Cornelia F. Allaart [Pays-Bas] ; Joan Bathon [États-Unis] ; Stefano Bombardieri [Italie] ; Peter Brooks [Australie] ; Andrew Brown [Royaume-Uni] ; Marco Matucci-Cerinic [Italie] ; Hyon Choi [États-Unis] ; Bernard Combe [France] ; Maarten De Wit [Royaume-Uni] ; Maxime Dougados [France] ; Paul Emery [Royaume-Uni] ; Daniel Furst [États-Unis] ; Juan Gomez-Reino [Espagne] ; Gillian Hawker ; Edward Keystone ; Dinesh Khanna [États-Unis] ; John Kirwan ; Tore K. Kvien ; Robert Landewe ; Joachim Listing ; Kaleb Michaud ; Emilio Martin-Mola ; Pamela Montie ; Theodore Pincus ; Pamela Richards ; Jeffrey N. Siegel ; Lee S. Simon ; Tuulikki Sokka ; Vibeke Strand ; Peter Tugwell [Canada] ; Alan Tyndall ; Desirée Van Der Heijde [Pays-Bas] ; Suzan Verstappen ; Barbara White ; Frederick Wolfe ; Angela Zink ; Maarten Boers [Pays-Bas]

Source :

RBID : Pascal:11-0199749

Descripteurs français

English descriptors

Abstract

Objective. Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. Methods. A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of 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 radiographic and functional outcomes. Results. Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (e.g., tender and swollen joint counts, C-reactive protein [CRP] level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year followup data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (a) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤1, or (b) when the score on the Simplified Disease Activity Index is ≤3.3. Conclusion. 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 as an outcome measure in each trial and that the results on both be reported for each trial.
pA  
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A02 01      @0 ARHEAW
A03   1    @0 Arthritis rheum.
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A08 01  1  ENG  @1 American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials
A11 01  1    @1 FELSON (David T.)
A11 02  1    @1 SMOLEN (Josef S.)
A11 03  1    @1 WELLS (George)
A11 04  1    @1 BIN ZHANG
A11 05  1    @1 VAN TUYL (Lilian H. D.)
A11 06  1    @1 FUNOVITS (Julia)
A11 07  1    @1 ALETAHA (Daniel)
A11 08  1    @1 ALLAART (Cornelia F.)
A11 09  1    @1 BATHON (Joan)
A11 10  1    @1 BOMBARDIERI (Stefano)
A11 11  1    @1 BROOKS (Peter)
A11 12  1    @1 BROWN (Andrew)
A11 13  1    @1 MATUCCI-CERINIC (Marco)
A11 14  1    @1 CHOI (Hyon)
A11 15  1    @1 COMBE (Bernard)
A11 16  1    @1 DE WIT (Maarten)
A11 17  1    @1 DOUGADOS (Maxime)
A11 18  1    @1 EMERY (Paul)
A11 19  1    @1 FURST (Daniel)
A11 20  1    @1 GOMEZ-REINO (Juan)
A11 21  1    @1 HAWKER (Gillian)
A11 22  1    @1 KEYSTONE (Edward)
A11 23  1    @1 KHANNA (Dinesh)
A11 24  1    @1 KIRWAN (John)
A11 25  1    @1 KVIEN (Tore K.)
A11 26  1    @1 LANDEWE (Robert)
A11 27  1    @1 LISTING (Joachim)
A11 28  1    @1 MICHAUD (Kaleb)
A11 29  1    @1 MARTIN-MOLA (Emilio)
A11 30  1    @1 MONTIE (Pamela)
A11 31  1    @1 PINCUS (Theodore)
A11 32  1    @1 RICHARDS (Pamela)
A11 33  1    @1 SIEGEL (Jeffrey N.)
A11 34  1    @1 SIMON (Lee S.)
A11 35  1    @1 SOKKA (Tuulikki)
A11 36  1    @1 STRAND (Vibeke)
A11 37  1    @1 TUGWELL (Peter)
A11 38  1    @1 TYNDALL (Alan)
A11 39  1    @1 VAN DER HEIJDE (Desirée)
A11 40  1    @1 VERSTAPPEN (Suzan)
A11 41  1    @1 WHITE (Barbara)
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A11 44  1    @1 BOERS (Maarten)
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A14 03      @1 Medical University of Vienna and Hietzing Hospital @2 Vienna @3 AUT @Z 2 aut.
A14 04      @1 University of Ottawa @2 Ottawa, Ontario @3 CAN @Z 3 aut. @Z 37 aut.
A14 05      @1 Boston University School of Medicine @2 Boston, Massachusetts @3 USA @Z 4 aut.
A14 06      @1 VU University Medical Center @2 Amsterdam @3 NLD @Z 5 aut. @Z 44 aut.
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A14 14      @1 Montpellier University Hospital @2 Montpellier @3 FRA @Z 15 aut.
A14 15      @1 Paris-Descartes University, UPRES-EA, Assistance Publique Hôpitaux de Paris, and Cochin Hospital @2 Paris @3 FRA @Z 17 aut.
A14 16      @1 University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit @2 Leeds @3 GBR @Z 16 aut. @Z 18 aut.
A14 17      @1 David Geffen School of Medicine at the University of California in Los Angeles @3 USA @Z 19 aut. @Z 23 aut.
A14 18      @1 Hospital Clinico Universitario and Universidad de Santiago de Compostela @2 Santiago @3 ESP @Z 20 aut.
A20       @1 573-586
A21       @1 2011
A23 01      @0 ENG
A43 01      @1 INIST @2 8711 @5 354000190790200010
A44       @0 0000 @1 © 2011 INIST-CNRS. All rights reserved.
A45       @0 68 ref.
A47 01  1    @0 11-0199749
A60       @1 P
A61       @0 A
A64 01  1    @0 Arthritis and rheumatism
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C01 01    ENG  @0 Objective. Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. Methods. A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of 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 radiographic and functional outcomes. Results. Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (e.g., tender and swollen joint counts, C-reactive protein [CRP] level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year followup data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (a) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤1, or (b) when the score on the Simplified Disease Activity Index is ≤3.3. Conclusion. 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 as an outcome measure in each trial and that the results on both be reported for each trial.
C02 01  X    @0 002B15I
C02 02  X    @0 002B15D
C03 01  X  FRE  @0 Polyarthrite rhumatoïde @5 01
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C03 06  X  SPA  @0 Crónico @5 30
C07 01  X  FRE  @0 Rhumatisme inflammatoire @5 37
C07 01  X  ENG  @0 Inflammatory joint disease @5 37
C07 01  X  SPA  @0 Reumatismo inflamatorio @5 37
C07 02  X  FRE  @0 Pathologie du système ostéoarticulaire @5 38
C07 02  X  ENG  @0 Diseases of the osteoarticular system @5 38
C07 02  X  SPA  @0 Sistema osteoarticular patología @5 38
C07 03  X  FRE  @0 Maladie autoimmune @5 39
C07 03  X  ENG  @0 Autoimmune disease @5 39
C07 03  X  SPA  @0 Enfermedad autoinmune @5 39
C07 04  X  FRE  @0 Immunopathologie @5 40
C07 04  X  ENG  @0 Immunopathology @5 40
C07 04  X  SPA  @0 Inmunopatología @5 40
N21       @1 129
N44 01      @1 OTO
N82       @1 OTO

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Pascal:11-0199749

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<name sortKey="Matucci Cerinic, Marco" sort="Matucci Cerinic, Marco" uniqKey="Matucci Cerinic M" first="Marco" last="Matucci-Cerinic">Marco Matucci-Cerinic</name>
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<name sortKey="De Wit, Maarten" sort="De Wit, Maarten" uniqKey="De Wit M" first="Maarten" last="De Wit">Maarten De Wit</name>
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<name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name>
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<name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name>
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<s1>University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit</s1>
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<name sortKey="Furst, Daniel" sort="Furst, Daniel" uniqKey="Furst D" first="Daniel" last="Furst">Daniel Furst</name>
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<name sortKey="Gomez Reino, Juan" sort="Gomez Reino, Juan" uniqKey="Gomez Reino J" first="Juan" last="Gomez-Reino">Juan Gomez-Reino</name>
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<name sortKey="Hawker, Gillian" sort="Hawker, Gillian" uniqKey="Hawker G" first="Gillian" last="Hawker">Gillian Hawker</name>
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<name sortKey="Keystone, Edward" sort="Keystone, Edward" uniqKey="Keystone E" first="Edward" last="Keystone">Edward Keystone</name>
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<name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name>
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<title xml:lang="en" level="a">American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials</title>
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<name sortKey="Felson, David T" sort="Felson, David T" uniqKey="Felson D" first="David T." last="Felson">David T. Felson</name>
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<inist:fA14 i1="13">
<s1>University of Florence</s1>
<s2>Florence</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
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</affiliation>
</author>
<author>
<name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S." last="Smolen">Josef S. Smolen</name>
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<inist:fA14 i1="02">
<s1>University of Manchester</s1>
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</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
<affiliation wicri:level="1">
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<s1>Medical University of Vienna and Hietzing Hospital</s1>
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</inist:fA14>
<country>Autriche</country>
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</author>
<author>
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</inist:fA14>
<country>Canada</country>
</affiliation>
</author>
<author>
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<sZ>4 aut.</sZ>
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<affiliation wicri:level="1">
<inist:fA14 i1="05">
<s1>Boston University School of Medicine</s1>
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<s3>USA</s3>
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<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>
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<inist:fA14 i1="06">
<s1>VU University Medical Center</s1>
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<sZ>5 aut.</sZ>
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</inist:fA14>
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<author>
<name sortKey="Funovits, Julia" sort="Funovits, Julia" uniqKey="Funovits J" first="Julia" last="Funovits">Julia Funovits</name>
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<author>
<name sortKey="Aletaha, Daniel" sort="Aletaha, Daniel" uniqKey="Aletaha D" first="Daniel" last="Aletaha">Daniel Aletaha</name>
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<s1>Medical University of Vienna</s1>
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<author>
<name sortKey="Allaart, Cornelia F" sort="Allaart, Cornelia F" uniqKey="Allaart C" first="Cornelia F." last="Allaart">Cornelia F. Allaart</name>
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<author>
<name sortKey="Bathon, Joan" sort="Bathon, Joan" uniqKey="Bathon J" first="Joan" last="Bathon">Joan Bathon</name>
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<author>
<name sortKey="Bombardieri, Stefano" sort="Bombardieri, Stefano" uniqKey="Bombardieri S" first="Stefano" last="Bombardieri">Stefano Bombardieri</name>
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</inist:fA14>
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</affiliation>
</author>
<author>
<name sortKey="Brooks, Peter" sort="Brooks, Peter" uniqKey="Brooks P" first="Peter" last="Brooks">Peter Brooks</name>
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<inist:fA14 i1="11">
<s1>University of Melbourne, Melbourne</s1>
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<sZ>11 aut.</sZ>
</inist:fA14>
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</author>
<author>
<name sortKey="Brown, Andrew" sort="Brown, Andrew" uniqKey="Brown A" first="Andrew" last="Brown">Andrew Brown</name>
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<author>
<name sortKey="Matucci Cerinic, Marco" sort="Matucci Cerinic, Marco" uniqKey="Matucci Cerinic M" first="Marco" last="Matucci-Cerinic">Marco Matucci-Cerinic</name>
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<author>
<name sortKey="Choi, Hyon" sort="Choi, Hyon" uniqKey="Choi H" first="Hyon" last="Choi">Hyon Choi</name>
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<inist:fA14 i1="01">
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<sZ>4 aut.</sZ>
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<author>
<name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
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<author>
<name sortKey="De Wit, Maarten" sort="De Wit, Maarten" uniqKey="De Wit M" first="Maarten" last="De Wit">Maarten De Wit</name>
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<author>
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<author>
<name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name>
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<inist:fA14 i1="18">
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<name sortKey="Siegel, Jeffrey N" sort="Siegel, Jeffrey N" uniqKey="Siegel J" first="Jeffrey N." last="Siegel">Jeffrey N. Siegel</name>
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<name sortKey="Sokka, Tuulikki" sort="Sokka, Tuulikki" uniqKey="Sokka T" first="Tuulikki" last="Sokka">Tuulikki Sokka</name>
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<s1>University of Ottawa</s1>
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<title level="j" type="main">Arthritis and rheumatism</title>
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<term>Polyarthrite rhumatoïde</term>
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<div type="abstract" xml:lang="en">Objective. Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. Methods. A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of 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 radiographic and functional outcomes. Results. Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (e.g., tender and swollen joint counts, C-reactive protein [CRP] level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year followup data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (a) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤1, or (b) when the score on the Simplified Disease Activity Index is ≤3.3. Conclusion. 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 as an outcome measure in each trial and that the results on both be reported for each trial.</div>
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