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A treat-to-target strategy with methotrexate and intra-articular triamcinolone with or without adalimumab effectively reduces MRI synovitis, osteitis and tenosynovitis and halts structural damage progression in early rheumatoid arthritis: results from the OPERA randomised controlled trial.

Identifieur interne : 000241 ( Main/Exploration ); précédent : 000240; suivant : 000242

A treat-to-target strategy with methotrexate and intra-articular triamcinolone with or without adalimumab effectively reduces MRI synovitis, osteitis and tenosynovitis and halts structural damage progression in early rheumatoid arthritis: results from the OPERA randomised controlled trial.

Auteurs : Mette Bj Rndal Axelsen [Danemark] ; Iris Eshed [Israël] ; Kim H Rslev-Petersen [Danemark] ; Kristian Stengaard-Pedersen [Danemark] ; Merete Lund Hetland [Danemark] ; Jakob M Ller [Danemark] ; Peter Junker [Danemark] ; Jan P Denphant [Danemark] ; Annette Schlemmer [Danemark] ; Torkell Ellingsen [Danemark] ; Palle Ahlquist [Danemark] ; Hanne Lindegaard [Danemark] ; Asta Linauskas [Danemark] ; Mette Yde Dam [Danemark] ; Ib Hansen [Danemark] ; Hans Christian Horn [Danemark] ; Christian Gytz Ammitzb Ll [Danemark] ; Anette J Rgensen [Danemark] ; Sophine B. Krintel [Danemark] ; Johnny Raun [Danemark] ; Niels S. Krogh [Danemark] ; Julia Sidenius Johansen [Danemark] ; Mikkel Stergaard [Danemark]

Source :

RBID : pubmed:24412895

Mots-clés :

Abstract

To investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses MRI inflammation and halts structural damage progression in patients with early rheumatoid arthritis (ERA), and whether adalimumab provides an additional effect.


DOI: 10.1136/annrheumdis-2013-204537


Affiliations:


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Le document en format XML

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<name sortKey="Linauskas, Asta" sort="Linauskas, Asta" uniqKey="Linauskas A" first="Asta" last="Linauskas">Asta Linauskas</name>
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<name sortKey="Dam, Mette Yde" sort="Dam, Mette Yde" uniqKey="Dam M" first="Mette Yde" last="Dam">Mette Yde Dam</name>
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<name sortKey="Hansen, Ib" sort="Hansen, Ib" uniqKey="Hansen I" first="Ib" last="Hansen">Ib Hansen</name>
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<nlm:affiliation>Department of Rheumatology, Viborg Regional Hospital, Viborg, Denmark.</nlm:affiliation>
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<name sortKey="Horn, Hans Christian" sort="Horn, Hans Christian" uniqKey="Horn H" first="Hans Christian" last="Horn">Hans Christian Horn</name>
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<name sortKey="Ammitzb Ll, Christian Gytz" sort="Ammitzb Ll, Christian Gytz" uniqKey="Ammitzb Ll C" first="Christian Gytz" last="Ammitzb Ll">Christian Gytz Ammitzb Ll</name>
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<name sortKey="Krintel, Sophine B" sort="Krintel, Sophine B" uniqKey="Krintel S" first="Sophine B" last="Krintel">Sophine B. Krintel</name>
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<name sortKey="Raun, Johnny" sort="Raun, Johnny" uniqKey="Raun J" first="Johnny" last="Raun">Johnny Raun</name>
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<nlm:affiliation>King Christian 10th Hospital for Rheumatic Diseases, Gråsten, Denmark South Jutland Hospital, Institute of Regional Health Services Research, University of Southern Denmark, Denmark.</nlm:affiliation>
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<name sortKey="Johansen, Julia Sidenius" sort="Johansen, Julia Sidenius" uniqKey="Johansen J" first="Julia Sidenius" last="Johansen">Julia Sidenius Johansen</name>
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<name sortKey=" Stergaard, Mikkel" sort=" Stergaard, Mikkel" uniqKey=" Stergaard M" first="Mikkel" last=" Stergaard">Mikkel Stergaard</name>
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<nlm:affiliation>Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark The DANBIO Registry, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark The DANBIO Registry, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup</wicri:regionArea>
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<title xml:lang="en">A treat-to-target strategy with methotrexate and intra-articular triamcinolone with or without adalimumab effectively reduces MRI synovitis, osteitis and tenosynovitis and halts structural damage progression in early rheumatoid arthritis: results from the OPERA randomised controlled trial.</title>
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<name sortKey="Axelsen, Mette Bj Rndal" sort="Axelsen, Mette Bj Rndal" uniqKey="Axelsen M" first="Mette Bj Rndal" last="Axelsen">Mette Bj Rndal Axelsen</name>
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<name sortKey="H Rslev Petersen, Kim" sort="H Rslev Petersen, Kim" uniqKey="H Rslev Petersen K" first="Kim" last="H Rslev-Petersen">Kim H Rslev-Petersen</name>
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<country xml:lang="fr">Danemark</country>
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<name sortKey="M Ller, Jakob" sort="M Ller, Jakob" uniqKey="M Ller J" first="Jakob" last="M Ller">Jakob M Ller</name>
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<name sortKey="Junker, Peter" sort="Junker, Peter" uniqKey="Junker P" first="Peter" last="Junker">Peter Junker</name>
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<country xml:lang="fr">Danemark</country>
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<name sortKey="P Denphant, Jan" sort="P Denphant, Jan" uniqKey="P Denphant J" first="Jan" last="P Denphant">Jan P Denphant</name>
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<nlm:affiliation>Department of Rheumatology, Copenhagen University Hospital at Gentofte, Gentofte, Denmark Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Rheumatology, Copenhagen University Hospital at Gentofte, Gentofte, Denmark Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen</wicri:regionArea>
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<settlement type="city">Copenhague</settlement>
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<name sortKey="Schlemmer, Annette" sort="Schlemmer, Annette" uniqKey="Schlemmer A" first="Annette" last="Schlemmer">Annette Schlemmer</name>
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<nlm:affiliation>Department of Rheumatology, Aarhus University Hospital in Aalborg, Aalborg, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
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<name sortKey="Ellingsen, Torkell" sort="Ellingsen, Torkell" uniqKey="Ellingsen T" first="Torkell" last="Ellingsen">Torkell Ellingsen</name>
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<nlm:affiliation>Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
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<name sortKey="Ahlquist, Palle" sort="Ahlquist, Palle" uniqKey="Ahlquist P" first="Palle" last="Ahlquist">Palle Ahlquist</name>
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<nlm:affiliation>Department of Rheumatology C, Odense University Hospital, University of Southern Denmark, Odense, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Rheumatology C, Odense University Hospital, University of Southern Denmark, Odense</wicri:regionArea>
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<name sortKey="Linauskas, Asta" sort="Linauskas, Asta" uniqKey="Linauskas A" first="Asta" last="Linauskas">Asta Linauskas</name>
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<nlm:affiliation>Department of Rheumatology, Vendsyssel Hospital, Hjørring, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Rheumatology, Vendsyssel Hospital, Hjørring</wicri:regionArea>
<wicri:noRegion>Hjørring</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Dam, Mette Yde" sort="Dam, Mette Yde" uniqKey="Dam M" first="Mette Yde" last="Dam">Mette Yde Dam</name>
<affiliation wicri:level="1">
<nlm:affiliation>Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg</wicri:regionArea>
<wicri:noRegion>Silkeborg</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Hansen, Ib" sort="Hansen, Ib" uniqKey="Hansen I" first="Ib" last="Hansen">Ib Hansen</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Rheumatology, Viborg Regional Hospital, Viborg, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Rheumatology, Viborg Regional Hospital, Viborg</wicri:regionArea>
<wicri:noRegion>Viborg</wicri:noRegion>
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</author>
<author>
<name sortKey="Horn, Hans Christian" sort="Horn, Hans Christian" uniqKey="Horn H" first="Hans Christian" last="Horn">Hans Christian Horn</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Medicine, Vejle Regional Hospital, Vejle, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Medicine, Vejle Regional Hospital, Vejle</wicri:regionArea>
<wicri:noRegion>Vejle</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Ammitzb Ll, Christian Gytz" sort="Ammitzb Ll, Christian Gytz" uniqKey="Ammitzb Ll C" first="Christian Gytz" last="Ammitzb Ll">Christian Gytz Ammitzb Ll</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Rheumatology, Aarhus University Hospital, Aarhus</wicri:regionArea>
<wicri:noRegion>Aarhus</wicri:noRegion>
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</author>
<author>
<name sortKey="J Rgensen, Anette" sort="J Rgensen, Anette" uniqKey="J Rgensen A" first="Anette" last="J Rgensen">Anette J Rgensen</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Rheumatology, Aarhus University Hospital, Aarhus</wicri:regionArea>
<wicri:noRegion>Aarhus</wicri:noRegion>
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</author>
<author>
<name sortKey="Krintel, Sophine B" sort="Krintel, Sophine B" uniqKey="Krintel S" first="Sophine B" last="Krintel">Sophine B. Krintel</name>
<affiliation wicri:level="1">
<nlm:affiliation>Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup</wicri:regionArea>
<wicri:noRegion>Glostrup</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Raun, Johnny" sort="Raun, Johnny" uniqKey="Raun J" first="Johnny" last="Raun">Johnny Raun</name>
<affiliation wicri:level="1">
<nlm:affiliation>King Christian 10th Hospital for Rheumatic Diseases, Gråsten, Denmark South Jutland Hospital, Institute of Regional Health Services Research, University of Southern Denmark, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>King Christian 10th Hospital for Rheumatic Diseases, Gråsten, Denmark South Jutland Hospital, Institute of Regional Health Services Research, University of Southern Denmark</wicri:regionArea>
<wicri:noRegion>University of Southern Denmark</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Krogh, Niels S" sort="Krogh, Niels S" uniqKey="Krogh N" first="Niels S" last="Krogh">Niels S. Krogh</name>
<affiliation wicri:level="3">
<nlm:affiliation>Zitelabs Aps, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Zitelabs Aps, Copenhagen</wicri:regionArea>
<placeName>
<settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Johansen, Julia Sidenius" sort="Johansen, Julia Sidenius" uniqKey="Johansen J" first="Julia Sidenius" last="Johansen">Julia Sidenius Johansen</name>
<affiliation wicri:level="1">
<nlm:affiliation>Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark Department of Medicine and Oncology, Copenhagen University Hospital at Herlev, Herlev, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark Department of Medicine and Oncology, Copenhagen University Hospital at Herlev, Herlev</wicri:regionArea>
<wicri:noRegion>Herlev</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey=" Stergaard, Mikkel" sort=" Stergaard, Mikkel" uniqKey=" Stergaard M" first="Mikkel" last=" Stergaard">Mikkel Stergaard</name>
<affiliation wicri:level="1">
<nlm:affiliation>Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark The DANBIO Registry, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark The DANBIO Registry, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup</wicri:regionArea>
<wicri:noRegion>Glostrup</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Annals of the rheumatic diseases</title>
<idno type="e-ISSN">1468-2060</idno>
<imprint>
<date when="2015" type="published">2015</date>
</imprint>
</series>
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<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Adalimumab</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Anti-Inflammatory Agents (therapeutic use)</term>
<term>Antibodies, Monoclonal, Humanized (therapeutic use)</term>
<term>Antirheumatic Agents (therapeutic use)</term>
<term>Arthritis, Rheumatoid (complications)</term>
<term>Arthritis, Rheumatoid (drug therapy)</term>
<term>Arthritis, Rheumatoid (pathology)</term>
<term>Clinical Protocols</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Humans</term>
<term>Injections, Intra-Articular</term>
<term>Magnetic Resonance Imaging</term>
<term>Male</term>
<term>Metacarpophalangeal Joint (pathology)</term>
<term>Methotrexate (therapeutic use)</term>
<term>Middle Aged</term>
<term>Osteitis (drug therapy)</term>
<term>Osteitis (etiology)</term>
<term>Osteitis (pathology)</term>
<term>Patient Care Planning</term>
<term>Severity of Illness Index</term>
<term>Synovitis (drug therapy)</term>
<term>Synovitis (etiology)</term>
<term>Synovitis (pathology)</term>
<term>Tenosynovitis (drug therapy)</term>
<term>Tenosynovitis (etiology)</term>
<term>Tenosynovitis (pathology)</term>
<term>Treatment Outcome</term>
<term>Triamcinolone (therapeutic use)</term>
<term>Wrist Joint (pathology)</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en">
<term>Anti-Inflammatory Agents</term>
<term>Antibodies, Monoclonal, Humanized</term>
<term>Antirheumatic Agents</term>
<term>Methotrexate</term>
<term>Triamcinolone</term>
</keywords>
<keywords scheme="MESH" type="chemical" xml:lang="en">
<term>Adalimumab</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en">
<term>Arthritis, Rheumatoid</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Arthritis, Rheumatoid</term>
<term>Osteitis</term>
<term>Synovitis</term>
<term>Tenosynovitis</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en">
<term>Osteitis</term>
<term>Synovitis</term>
<term>Tenosynovitis</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en">
<term>Arthritis, Rheumatoid</term>
<term>Metacarpophalangeal Joint</term>
<term>Osteitis</term>
<term>Synovitis</term>
<term>Tenosynovitis</term>
<term>Wrist Joint</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Clinical Protocols</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Humans</term>
<term>Injections, Intra-Articular</term>
<term>Magnetic Resonance Imaging</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Patient Care Planning</term>
<term>Severity of Illness Index</term>
<term>Treatment Outcome</term>
<term>Young Adult</term>
</keywords>
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<front>
<div type="abstract" xml:lang="en">To investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses MRI inflammation and halts structural damage progression in patients with early rheumatoid arthritis (ERA), and whether adalimumab provides an additional effect.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Danemark</li>
<li>Israël</li>
</country>
<region>
<li>Hovedstaden</li>
</region>
<settlement>
<li>Copenhague</li>
</settlement>
</list>
<tree>
<country name="Danemark">
<region name="Hovedstaden">
<name sortKey="Axelsen, Mette Bj Rndal" sort="Axelsen, Mette Bj Rndal" uniqKey="Axelsen M" first="Mette Bj Rndal" last="Axelsen">Mette Bj Rndal Axelsen</name>
</region>
<name sortKey=" Stergaard, Mikkel" sort=" Stergaard, Mikkel" uniqKey=" Stergaard M" first="Mikkel" last=" Stergaard">Mikkel Stergaard</name>
<name sortKey="Ahlquist, Palle" sort="Ahlquist, Palle" uniqKey="Ahlquist P" first="Palle" last="Ahlquist">Palle Ahlquist</name>
<name sortKey="Ammitzb Ll, Christian Gytz" sort="Ammitzb Ll, Christian Gytz" uniqKey="Ammitzb Ll C" first="Christian Gytz" last="Ammitzb Ll">Christian Gytz Ammitzb Ll</name>
<name sortKey="Dam, Mette Yde" sort="Dam, Mette Yde" uniqKey="Dam M" first="Mette Yde" last="Dam">Mette Yde Dam</name>
<name sortKey="Ellingsen, Torkell" sort="Ellingsen, Torkell" uniqKey="Ellingsen T" first="Torkell" last="Ellingsen">Torkell Ellingsen</name>
<name sortKey="H Rslev Petersen, Kim" sort="H Rslev Petersen, Kim" uniqKey="H Rslev Petersen K" first="Kim" last="H Rslev-Petersen">Kim H Rslev-Petersen</name>
<name sortKey="Hansen, Ib" sort="Hansen, Ib" uniqKey="Hansen I" first="Ib" last="Hansen">Ib Hansen</name>
<name sortKey="Hetland, Merete Lund" sort="Hetland, Merete Lund" uniqKey="Hetland M" first="Merete Lund" last="Hetland">Merete Lund Hetland</name>
<name sortKey="Horn, Hans Christian" sort="Horn, Hans Christian" uniqKey="Horn H" first="Hans Christian" last="Horn">Hans Christian Horn</name>
<name sortKey="J Rgensen, Anette" sort="J Rgensen, Anette" uniqKey="J Rgensen A" first="Anette" last="J Rgensen">Anette J Rgensen</name>
<name sortKey="Johansen, Julia Sidenius" sort="Johansen, Julia Sidenius" uniqKey="Johansen J" first="Julia Sidenius" last="Johansen">Julia Sidenius Johansen</name>
<name sortKey="Junker, Peter" sort="Junker, Peter" uniqKey="Junker P" first="Peter" last="Junker">Peter Junker</name>
<name sortKey="Krintel, Sophine B" sort="Krintel, Sophine B" uniqKey="Krintel S" first="Sophine B" last="Krintel">Sophine B. Krintel</name>
<name sortKey="Krogh, Niels S" sort="Krogh, Niels S" uniqKey="Krogh N" first="Niels S" last="Krogh">Niels S. Krogh</name>
<name sortKey="Linauskas, Asta" sort="Linauskas, Asta" uniqKey="Linauskas A" first="Asta" last="Linauskas">Asta Linauskas</name>
<name sortKey="Lindegaard, Hanne" sort="Lindegaard, Hanne" uniqKey="Lindegaard H" first="Hanne" last="Lindegaard">Hanne Lindegaard</name>
<name sortKey="M Ller, Jakob" sort="M Ller, Jakob" uniqKey="M Ller J" first="Jakob" last="M Ller">Jakob M Ller</name>
<name sortKey="P Denphant, Jan" sort="P Denphant, Jan" uniqKey="P Denphant J" first="Jan" last="P Denphant">Jan P Denphant</name>
<name sortKey="Raun, Johnny" sort="Raun, Johnny" uniqKey="Raun J" first="Johnny" last="Raun">Johnny Raun</name>
<name sortKey="Schlemmer, Annette" sort="Schlemmer, Annette" uniqKey="Schlemmer A" first="Annette" last="Schlemmer">Annette Schlemmer</name>
<name sortKey="Stengaard Pedersen, Kristian" sort="Stengaard Pedersen, Kristian" uniqKey="Stengaard Pedersen K" first="Kristian" last="Stengaard-Pedersen">Kristian Stengaard-Pedersen</name>
</country>
<country name="Israël">
<noRegion>
<name sortKey="Eshed, Iris" sort="Eshed, Iris" uniqKey="Eshed I" first="Iris" last="Eshed">Iris Eshed</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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   |texte=   A treat-to-target strategy with methotrexate and intra-articular triamcinolone with or without adalimumab effectively reduces MRI synovitis, osteitis and tenosynovitis and halts structural damage progression in early rheumatoid arthritis: results from the OPERA randomised controlled trial.
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