schliessen

Filtern

 

Bibliotheken

American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials

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. A committee... Full description

Journal Title: Annals of the rheumatic diseases 2011, Vol.63 (3), p.573-586
Main Author: Felson, David T
Other Authors: Smolen, Josef S , Wells, George , Zhang, Bin , van Tuyl, Lilian H. D , Funovits, Julia , Aletaha, Daniel , Allaart, Cornelia F , Bathon, Joan , Bombardieri, Stefano , Brooks, Peter , Brown, Anew , Matucci-Cerinic, Marco , Choi, Hyon , Combe, Bernard , de Wit, Maarten , Dougados, Maxime , Emery, Paul , Furst, Daniel , Gomez-Reino, Juan , Hawker, Gillian , Keystone, Edward , Khanna, Dinesh , Kirwan, John , Kvien, Tore K , Landewé, Robert , Listing, Joachim , Michaud, Kaleb , Martin-Mola, Emilio , Montie, Pamela , Pincus, Theodore , Richards, Pamela , Siegel, Jeffrey N , Simon, Lee S , Sokka, Tuulikki , Strand, Vibeke , Tugwell, Peter , Tyndall, Alan , van der Heijde, Desirée , Verstappen, Suzan , White, Barbara , Wolfe, Frederick , Zink, Angela , Boers, Maarten
Format: Electronic Article Electronic Article
Language: English
Subjects:
Non
Publisher: Hoboken: Wiley Subscription Services, Inc., A Wiley Company
ID: ISSN: 0004-3591
Zum Text:
SendSend as email Add to Book BagAdd to Book Bag
Staff View
recordid: cdi_gale_infotracmisc_A250244988
title: American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials
format: Article
creator:
  • Felson, David T
  • Smolen, Josef S
  • Wells, George
  • Zhang, Bin
  • van Tuyl, Lilian H. D
  • Funovits, Julia
  • Aletaha, Daniel
  • Allaart, Cornelia F
  • Bathon, Joan
  • Bombardieri, Stefano
  • Brooks, Peter
  • Brown, Anew
  • Matucci-Cerinic, Marco
  • Choi, Hyon
  • Combe, Bernard
  • de Wit, Maarten
  • Dougados, Maxime
  • Emery, Paul
  • Furst, Daniel
  • Gomez-Reino, Juan
  • Hawker, Gillian
  • Keystone, Edward
  • Khanna, Dinesh
  • Kirwan, John
  • Kvien, Tore K
  • Landewé, Robert
  • Listing, Joachim
  • Michaud, Kaleb
  • Martin-Mola, Emilio
  • Montie, Pamela
  • Pincus, Theodore
  • Richards, Pamela
  • Siegel, Jeffrey N
  • Simon, Lee S
  • Sokka, Tuulikki
  • Strand, Vibeke
  • Tugwell, Peter
  • Tyndall, Alan
  • van der Heijde, Desirée
  • Verstappen, Suzan
  • White, Barbara
  • Wolfe, Frederick
  • Zink, Angela
  • Boers, Maarten
subjects:
  • Antirheumatic Agents - therapeutic use
  • Arthritis, Rheumatoid - drug therapy
  • atira
  • Biological and medical sciences
  • Care and treatment
  • Clinical trials
  • Clinical Trials as Topic - methods
  • Clinical Trials as Topic - standards
  • Consensus Development Conference
  • Data Collection
  • Diseases of the osteoarticular system
  • Drug therapy
  • Endpoint Determination
  • Europe
  • Extramural
  • Gov't
  • Humans
  • Inflammatory joint diseases
  • Journal Article
  • Medical sciences
  • Miscellaneous. Osteoarticular involvement in other diseases
  • Non
  • Outcome and process assessment (Health Care)
  • Prognosis
  • pubmedpublicationtype
  • pure
  • Remission Induction
  • Research Support
  • researchoutput
  • Rheumatoid arthritis
  • Rheumatology
  • Severity of Illness Index
  • Standards
  • Terminology
  • Terminology as Topic
  • Treatment Outcome
  • United States
ispartof: Annals of the rheumatic diseases, 2011, Vol.63 (3), p.573-586
description: 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. 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. 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. 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 t
language: eng
source:
identifier: ISSN: 0004-3591
fulltext: no_fulltext
issn:
  • 0004-3591
  • 0003-4967
  • 0893-7524
  • 1529-0131
  • 1468-2060
url: Link


@attributes
NO1
SEARCH_ENGINEprimo_central_multiple_fe
SEARCH_ENGINE_TYPEPrimo Central Search Engine
RANK2.7732475
LOCALfalse
PrimoNMBib
record
control
sourceidgale_opena
recordidTN_cdi_gale_infotracmisc_A250244988
sourceformatXML
sourcesystemPC
galeidA250244988
sourcerecordidA250244988
originalsourceidFETCH-LOGICAL-16859-38847ae090a3d8c1a6cd84ae21872480b8b1d6b1211d41e8ef2672c4b4f5cfce0
addsrcrecordideNqFkt1u1DAQhSMEoqVwwQugSIgLLnbXf3Gcy1VVfqQVSFW5xXLs8dZVEi920mqfgxdmtrttARWhXDhOvjOaOXOK4jUlc0oIW5g0zjmhrHlSHNOKNTNCOX1aHBNCxIxXDT0qXuR8hVfGK_68OGLIMsX5cfFz2UMK1gzlaew6WEMZfXl-CVNvxtjF9XZxNqW4AQRWYNYTlMu1CUMe76CQ-3KT4nXIIQ6mKx34MIQRL7tKCfqQd3_KMJTpUDa4Eju-TEjl0sdU2g4lFsVjCqbLL4tnHg94dThPim8fzi5OP81WXz9-Pl2uZlSqqplxpURtgDTEcKcsNdI6JQwwqmomFGlVS51sKaPUCQoKPJM1s6IVvrLeAjkpvuzr4nyDCQn0JoXepK2OJmg3wKgduGmjb7wmhGpWOSc8F9b4uq24qAU03rZNIxtJnXVY8O2-IBryY4I86qs4JXQla1rRmnBBpHig1qYDHQYfx2Qs-mT1klWECdEohdT8EQofh5baOKDN-P0Pwfu9wKaYcwJ_Pw0lehcTjabr25gg--bQ6NT24O7Ju1wg8O4AmIyL8ckMNuQHjje1Ikr-n1N1zRhDbvFXczaMZpcSnCp0j7Z4UNzgnNt_z6KX5xd3iu97xWDS702Y3uKYtzvdTLhkvOuhw_e2w9DtesD1MCUxTUJDTZkWYFttZOW0b6WgvgbZkpb8AgibEsM
sourcetypeOpen Access Repository
isCDItrue
recordtypearticle
pqid1517034064
display
typearticle
titleAmerican College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials
creatorFelson, David T ; Smolen, Josef S ; Wells, George ; Zhang, Bin ; van Tuyl, Lilian H. D ; Funovits, Julia ; Aletaha, Daniel ; Allaart, Cornelia F ; Bathon, Joan ; Bombardieri, Stefano ; Brooks, Peter ; Brown, Anew ; Matucci-Cerinic, Marco ; Choi, Hyon ; Combe, Bernard ; de Wit, Maarten ; Dougados, Maxime ; Emery, Paul ; Furst, Daniel ; Gomez-Reino, Juan ; Hawker, Gillian ; Keystone, Edward ; Khanna, Dinesh ; Kirwan, John ; Kvien, Tore K ; Landewé, Robert ; Listing, Joachim ; Michaud, Kaleb ; Martin-Mola, Emilio ; Montie, Pamela ; Pincus, Theodore ; Richards, Pamela ; Siegel, Jeffrey N ; Simon, Lee S ; Sokka, Tuulikki ; Strand, Vibeke ; Tugwell, Peter ; Tyndall, Alan ; van der Heijde, Desirée ; Verstappen, Suzan ; White, Barbara ; Wolfe, Frederick ; Zink, Angela ; Boers, Maarten
creatorcontribFelson, David T ; Smolen, Josef S ; Wells, George ; Zhang, Bin ; van Tuyl, Lilian H. D ; Funovits, Julia ; Aletaha, Daniel ; Allaart, Cornelia F ; Bathon, Joan ; Bombardieri, Stefano ; Brooks, Peter ; Brown, Anew ; Matucci-Cerinic, Marco ; Choi, Hyon ; Combe, Bernard ; de Wit, Maarten ; Dougados, Maxime ; Emery, Paul ; Furst, Daniel ; Gomez-Reino, Juan ; Hawker, Gillian ; Keystone, Edward ; Khanna, Dinesh ; Kirwan, John ; Kvien, Tore K ; Landewé, Robert ; Listing, Joachim ; Michaud, Kaleb ; Martin-Mola, Emilio ; Montie, Pamela ; Pincus, Theodore ; Richards, Pamela ; Siegel, Jeffrey N ; Simon, Lee S ; Sokka, Tuulikki ; Strand, Vibeke ; Tugwell, Peter ; Tyndall, Alan ; van der Heijde, Desirée ; Verstappen, Suzan ; White, Barbara ; Wolfe, Frederick ; Zink, Angela ; Boers, Maarten
descriptionRemission 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. 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. 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. 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
identifier
0ISSN: 0004-3591
1ISSN: 0003-4967
2ISSN: 0893-7524
3EISSN: 1529-0131
4EISSN: 1468-2060
5DOI: 10.1002/art.30129
6PMID: 21292833
7CODEN: ARDIAO
languageeng
publisherHoboken: Wiley Subscription Services, Inc., A Wiley Company
subjectAntirheumatic Agents - therapeutic use ; Arthritis, Rheumatoid - drug therapy ; atira ; Biological and medical sciences ; Care and treatment ; Clinical trials ; Clinical Trials as Topic - methods ; Clinical Trials as Topic - standards ; Consensus Development Conference ; Data Collection ; Diseases of the osteoarticular system ; Drug therapy ; Endpoint Determination ; Europe ; Extramural ; Gov't ; Humans ; Inflammatory joint diseases ; Journal Article ; Medical sciences ; Miscellaneous. Osteoarticular involvement in other diseases ; Non ; Outcome and process assessment (Health Care) ; Prognosis ; pubmedpublicationtype ; pure ; Remission Induction ; Research Support ; researchoutput ; Rheumatoid arthritis ; Rheumatology ; Severity of Illness Index ; Standards ; Terminology ; Terminology as Topic ; Treatment Outcome ; United States
ispartofAnnals of the rheumatic diseases, 2011, Vol.63 (3), p.573-586
rights
0info:eu-repo/semantics/restrictedAccess
1Copyright © 2011 by the American College of Rheumatology
22015 INIST-CNRS
lds50peer_reviewed
oafree_for_read
citedbyFETCH-LOGICAL-16859-38847ae090a3d8c1a6cd84ae21872480b8b1d6b1211d41e8ef2672c4b4f5cfce0
citesFETCH-LOGICAL-16859-38847ae090a3d8c1a6cd84ae21872480b8b1d6b1211d41e8ef2672c4b4f5cfce0
links
openurl$$Topenurl_article
thumbnail$$Usyndetics_thumb_exl
backlink
0$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23877222$$DView record in Pascal Francis
1$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23978086$$DView record in Pascal Francis
2$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21292833$$D View this record in MEDLINE/PubMed
search
creatorcontrib
0Felson, David T
1Smolen, Josef S
2Wells, George
3Zhang, Bin
4van Tuyl, Lilian H. D
5Funovits, Julia
6Aletaha, Daniel
7Allaart, Cornelia F
8Bathon, Joan
9Bombardieri, Stefano
10Brooks, Peter
11Brown, Anew
12Matucci-Cerinic, Marco
13Choi, Hyon
14Combe, Bernard
15de Wit, Maarten
16Dougados, Maxime
17Emery, Paul
18Furst, Daniel
19Gomez-Reino, Juan
20Hawker, Gillian
21Keystone, Edward
22Khanna, Dinesh
23Kirwan, John
24Kvien, Tore K
25Landewé, Robert
26Listing, Joachim
27Michaud, Kaleb
28Martin-Mola, Emilio
29Montie, Pamela
30Pincus, Theodore
31Richards, Pamela
32Siegel, Jeffrey N
33Simon, Lee S
34Sokka, Tuulikki
35Strand, Vibeke
36Tugwell, Peter
37Tyndall, Alan
38van der Heijde, Desirée
39Verstappen, Suzan
40White, Barbara
41Wolfe, Frederick
42Zink, Angela
43Boers, Maarten
title
0American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials
1Annals of the rheumatic diseases
addtitleAnn Rheum Dis
descriptionRemission 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. 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. 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. 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
subject
0Antirheumatic Agents - therapeutic use
1Arthritis, Rheumatoid - drug therapy
2atira
3Biological and medical sciences
4Care and treatment
5Clinical trials
6Clinical Trials as Topic - methods
7Clinical Trials as Topic - standards
8Consensus Development Conference
9Data Collection
10Diseases of the osteoarticular system
11Drug therapy
12Endpoint Determination
13Europe
14Extramural
15Gov't
16Humans
17Inflammatory joint diseases
18Journal Article
19Medical sciences
20Miscellaneous. Osteoarticular involvement in other diseases
21Non
22Outcome and process assessment (Health Care)
23Prognosis
24pubmedpublicationtype
25pure
26Remission Induction
27Research Support
28researchoutput
29Rheumatoid arthritis
30Rheumatology
31Severity of Illness Index
32Standards
33Terminology
34Terminology as Topic
35Treatment Outcome
36United States
issn
00004-3591
10003-4967
20893-7524
31529-0131
41468-2060
fulltextfalse
rsrctypearticle
creationdate2011
recordtypearticle
recordideNqFkt1u1DAQhSMEoqVwwQugSIgLLnbXf3Gcy1VVfqQVSFW5xXLs8dZVEi920mqfgxdmtrttARWhXDhOvjOaOXOK4jUlc0oIW5g0zjmhrHlSHNOKNTNCOX1aHBNCxIxXDT0qXuR8hVfGK_68OGLIMsX5cfFz2UMK1gzlaew6WEMZfXl-CVNvxtjF9XZxNqW4AQRWYNYTlMu1CUMe76CQ-3KT4nXIIQ6mKx34MIQRL7tKCfqQd3_KMJTpUDa4Eju-TEjl0sdU2g4lFsVjCqbLL4tnHg94dThPim8fzi5OP81WXz9-Pl2uZlSqqplxpURtgDTEcKcsNdI6JQwwqmomFGlVS51sKaPUCQoKPJM1s6IVvrLeAjkpvuzr4nyDCQn0JoXepK2OJmg3wKgduGmjb7wmhGpWOSc8F9b4uq24qAU03rZNIxtJnXVY8O2-IBryY4I86qs4JXQla1rRmnBBpHig1qYDHQYfx2Qs-mT1klWECdEohdT8EQofh5baOKDN-P0Pwfu9wKaYcwJ_Pw0lehcTjabr25gg--bQ6NT24O7Ju1wg8O4AmIyL8ckMNuQHjje1Ikr-n1N1zRhDbvFXczaMZpcSnCp0j7Z4UNzgnNt_z6KX5xd3iu97xWDS702Y3uKYtzvdTLhkvOuhw_e2w9DtesD1MCUxTUJDTZkWYFttZOW0b6WgvgbZkpb8AgibEsM
startdate2011
enddate2011
creator
0Felson, David T
1Smolen, Josef S
2Wells, George
3Zhang, Bin
4van Tuyl, Lilian H. D
5Funovits, Julia
6Aletaha, Daniel
7Allaart, Cornelia F
8Bathon, Joan
9Bombardieri, Stefano
10Brooks, Peter
11Brown, Anew
12Matucci-Cerinic, Marco
13Choi, Hyon
14Combe, Bernard
15de Wit, Maarten
16Dougados, Maxime
17Emery, Paul
18Furst, Daniel
19Gomez-Reino, Juan
20Hawker, Gillian
21Keystone, Edward
22Khanna, Dinesh
23Kirwan, John
24Kvien, Tore K
25Landewé, Robert
26Listing, Joachim
27Michaud, Kaleb
28Martin-Mola, Emilio
29Montie, Pamela
30Pincus, Theodore
31Richards, Pamela
32Siegel, Jeffrey N
33Simon, Lee S
34Sokka, Tuulikki
35Strand, Vibeke
36Tugwell, Peter
37Tyndall, Alan
38van der Heijde, Desirée
39Verstappen, Suzan
40White, Barbara
41Wolfe, Frederick
42Zink, Angela
43Boers, Maarten
general
0Wiley Subscription Services, Inc., A Wiley Company
1BMJ Publishing Group
2Wiley
3BMJ Publishing Group Ltd
4Wiley Subscription Services, Inc
scope
05DI
15DJ
2QVL
3IQODW
4CGR
5CUY
6CVF
7ECM
8EIF
9NPM
10AAYXX
11CITATION
12BSHEE
137QL
147QP
157T5
167TM
177U7
18C1K
19H94
20K9.
21BOBZL
22CLFQK
sort
creationdate2011
titleAmerican College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials
authorFelson, David T ; Smolen, Josef S ; Wells, George ; Zhang, Bin ; van Tuyl, Lilian H. D ; Funovits, Julia ; Aletaha, Daniel ; Allaart, Cornelia F ; Bathon, Joan ; Bombardieri, Stefano ; Brooks, Peter ; Brown, Anew ; Matucci-Cerinic, Marco ; Choi, Hyon ; Combe, Bernard ; de Wit, Maarten ; Dougados, Maxime ; Emery, Paul ; Furst, Daniel ; Gomez-Reino, Juan ; Hawker, Gillian ; Keystone, Edward ; Khanna, Dinesh ; Kirwan, John ; Kvien, Tore K ; Landewé, Robert ; Listing, Joachim ; Michaud, Kaleb ; Martin-Mola, Emilio ; Montie, Pamela ; Pincus, Theodore ; Richards, Pamela ; Siegel, Jeffrey N ; Simon, Lee S ; Sokka, Tuulikki ; Strand, Vibeke ; Tugwell, Peter ; Tyndall, Alan ; van der Heijde, Desirée ; Verstappen, Suzan ; White, Barbara ; Wolfe, Frederick ; Zink, Angela ; Boers, Maarten
facets
frbrtype5
frbrgroupidcdi_FETCH-LOGICAL-16859-38847ae090a3d8c1a6cd84ae21872480b8b1d6b1211d41e8ef2672c4b4f5cfce0
rsrctypearticles
prefilterarticles
languageeng
creationdate2011
topic
0Antirheumatic Agents - therapeutic use
1Arthritis, Rheumatoid - drug therapy
2atira
3Biological and medical sciences
4Care and treatment
5Clinical trials
6Clinical Trials as Topic - methods
7Clinical Trials as Topic - standards
8Consensus Development Conference
9Data Collection
10Diseases of the osteoarticular system
11Drug therapy
12Endpoint Determination
13Europe
14Extramural
15Gov't
16Humans
17Inflammatory joint diseases
18Journal Article
19Medical sciences
20Miscellaneous. Osteoarticular involvement in other diseases
21Non
22Outcome and process assessment (Health Care)
23Prognosis
24pubmedpublicationtype
25pure
26Remission Induction
27Research Support
28researchoutput
29Rheumatoid arthritis
30Rheumatology
31Severity of Illness Index
32Standards
33Terminology
34Terminology as Topic
35Treatment Outcome
36United States
toplevelpeer_reviewed
creatorcontrib
0Felson, David T
1Smolen, Josef S
2Wells, George
3Zhang, Bin
4van Tuyl, Lilian H. D
5Funovits, Julia
6Aletaha, Daniel
7Allaart, Cornelia F
8Bathon, Joan
9Bombardieri, Stefano
10Brooks, Peter
11Brown, Anew
12Matucci-Cerinic, Marco
13Choi, Hyon
14Combe, Bernard
15de Wit, Maarten
16Dougados, Maxime
17Emery, Paul
18Furst, Daniel
19Gomez-Reino, Juan
20Hawker, Gillian
21Keystone, Edward
22Khanna, Dinesh
23Kirwan, John
24Kvien, Tore K
25Landewé, Robert
26Listing, Joachim
27Michaud, Kaleb
28Martin-Mola, Emilio
29Montie, Pamela
30Pincus, Theodore
31Richards, Pamela
32Siegel, Jeffrey N
33Simon, Lee S
34Sokka, Tuulikki
35Strand, Vibeke
36Tugwell, Peter
37Tyndall, Alan
38van der Heijde, Desirée
39Verstappen, Suzan
40White, Barbara
41Wolfe, Frederick
42Zink, Angela
43Boers, Maarten
collection
0NARCIS
1NARCIS: Datasets
2NARCIS:Publications
3Pascal-Francis
4Medline
5MEDLINE
6MEDLINE (Ovid)
7MEDLINE
8MEDLINE
9PubMed
10CrossRef
11Academic OneFile (A&I only)
12Bacteriology Abstracts (Microbiology B)
13Calcium & Calcified Tissue Abstracts
14Immunology Abstracts
15Nucleic Acids Abstracts
16Toxicology Abstracts
17Environmental Sciences and Pollution Management
18AIDS and Cancer Research Abstracts
19ProQuest Health & Medical Complete (Alumni)
20OpenAIRE (Open Access)
21OpenAIRE
jtitleAnnals of the rheumatic diseases
delivery
delcategoryRemote Search Resource
fulltextno_fulltext
addata
au
0Felson, David T
1Smolen, Josef S
2Wells, George
3Zhang, Bin
4van Tuyl, Lilian H. D
5Funovits, Julia
6Aletaha, Daniel
7Allaart, Cornelia F
8Bathon, Joan
9Bombardieri, Stefano
10Brooks, Peter
11Brown, Anew
12Matucci-Cerinic, Marco
13Choi, Hyon
14Combe, Bernard
15de Wit, Maarten
16Dougados, Maxime
17Emery, Paul
18Furst, Daniel
19Gomez-Reino, Juan
20Hawker, Gillian
21Keystone, Edward
22Khanna, Dinesh
23Kirwan, John
24Kvien, Tore K
25Landewé, Robert
26Listing, Joachim
27Michaud, Kaleb
28Martin-Mola, Emilio
29Montie, Pamela
30Pincus, Theodore
31Richards, Pamela
32Siegel, Jeffrey N
33Simon, Lee S
34Sokka, Tuulikki
35Strand, Vibeke
36Tugwell, Peter
37Tyndall, Alan
38van der Heijde, Desirée
39Verstappen, Suzan
40White, Barbara
41Wolfe, Frederick
42Zink, Angela
43Boers, Maarten
formatjournal
genrearticle
ristypeJOUR
atitleAmerican College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials
jtitleAnnals of the rheumatic diseases
addtitleAnn Rheum Dis
date2011
risdate2011
volume63
issue3
spage573
epage586
pages573-586
issn
00004-3591
10003-4967
20893-7524
eissn
01529-0131
11468-2060
codenARDIAO
notes
0Dr. Aletaha has received consulting fees, speaking fees, and/or honoraria from Abbott, Roche, UCB, Bristol‐Myers Squibb, Schering‐Plough, and Wyeth (less than $10,000 each).
1Dr. Gomez‐Reino has received consulting fees, speaking fees, and/or honoraria from Schering‐Plough, Bristol‐Myers Squibb, Wyeth, Roche, and UCB (less than $10,000 each).
2Annals of the Rheumatic Diseases
3Dr. Choi has received honoraria for serving on advisory boards for TAP Pharmaceuticals and Savient (less than $10,000 each).
4Dr. Martin‐Mola has received consulting fees from Merck, Sharp, and Dohme, Pfizer, and Roche (less than $10,000 each).
5Dr. Allaart has received consulting fees, speaking fees, and/or honoraria from Schering‐Plough, Centocor, and UCB (less than $10,000 each).
6Dr. Khanna has received consulting fees, speaking fees, and/or honoraria from Abbott and UCB (less than $10,000 each).
7Dr. Sokka has received consulting fees, speaking fees, and/or honoraria from Abbott, Pfizer, and UCB (less than $10,000 each).
8Dr. Smolen has received consulting fees, speaking fees, and/or honoraria from Amgen, Abbott, Centocor, Schering‐Plough, Wyeth, Bristol‐Myers Squibb, Roche, UCB, and AstaZeneca (less than $10,000 each); he has received grants from Schering‐Plough, Roche, UCB, Bristol‐Myers Squibb, and Abbott.
9This article is published simultaneously in the March 2011 issue of
10Dr. Furst has received consulting fees, speaking fees, and/or honoraria from Abbott, Actelion, Amgen, Bristol‐Myers Squibb, Biogen Idec, Centocor, Genentech, Gilead, GlaxoSmithKline, Merck, Nitec, Novartis, UCB, Wyeth, and Xoma (less than $10,000 each); he has received research funding from Abbott, Actelion, Amgen, Bristol‐Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Nitec, Novartis, Roche, UCB, Wyeth, and Xoma.
11Dr. Pincus has received consulting fees, speaking fees, and/or honoraria from Amgen, Abbott, Bristol‐Myers Squibb, Centocor, UCB, Wyeth, and Genentech (less than $10,000 each) and research grants from Amgen, Bristol‐Myers Squibb, UCB, and Centocor.
12Dr. Bathon has received consulting fees, speaking fees, and/or honoraria from Crescendo Biosciences and Roche (less than $10,000 each); she has received research contracts from Biogen Idec.
13Dr. Landewé has received consulting fees, speaking fees, and/or honoraria from Abbott, Centocor, Schering‐Plough, Wyeth, Pfizer, UCB, Merck, Bristol‐Myers Squibb, and Amgen (less than $10,000 each).
14.
15Dr. Brown has received speaking fees and/or honoraria from Schering‐Plough, Abbott, and Pfizer (less than $10,000 each).
16Dr. Matucci‐Cerinic has provided paid consultation to Pfizer, Actelion, and Schering (less than $10,000 each).
17Dr. Tugwell has received consulting fees from Bristol‐Myers Squibb, Chelsea, and UCB (more than $10,000 each); he has received research grants from Aventis (HMR), Biomatrix, Cigna, Genzyme, Merck, Novartis, Parke Davis, Pfizer, Rhone‐Poulenc, Sandoz, and SmithKline Beecham.
18Dr. Simon has received consulting fees from Affinergy, AstraZeneca, Abraxis, Alpha Rx, Nuvo/Dimethaid Research, Roche, Pfizer, Novartis, PLx Pharma, Hisamitsu, Dr Reddys, Avanir, Cerimon, Alimera, Paraexel, Nitec, Bayer, Rigel, Chelsea, Regeneron, Cypress Biosciences, Nicox, Biocryst, Extera, Wyeth, Solace, Puretechventures, White Mountain Pharma, Abbott, Omeros, Jazz, Takeda, Teva, Zydus, Proprius, Alder, Cephalon, Seprecor, Purdue, EMD Merck Serono, Altea, Talagen, TiGenix, Antigenics, Forest, Genzyme, CaloSyn, King, Pozen, IL Pharma, Analgesic Solutions, and US WorldMeds (less than $10,000 each) and from Savient and Horizon (more than $10,000 each); owns stock or stock options in Savient; and has provided paid consultation to Leerink Swann, Luxor, Nomura, and Fidelity, investment analysis firms.
19Dr. Zink has received speaking fees from Abbott, Bristol‐Myers Squibb, Roche, Wyeth, and UCB (less than $10,000 each).
20Drs. Felson and Smolen contributed equally to this work.
21The views presented in this article do not necessarily reflect those of the United States Food and Drug Administration.
abstractRemission 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. 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. 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. 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
copHoboken
pubWiley Subscription Services, Inc., A Wiley Company
pmid21292833
doi10.1002/art.30129
tpages14
oafree_for_read