Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial
Published version. Source at http://dx.doi.org/10.1136/bmj.i4205 Objective: To determine whether a treatment strategy based on structured ultrasound assessment would lead to improved outcomes in rheumatoid arthritis, compared with a conventional strategy. Design: Multicentre, open label, two arm, pa...
Published in: | BMJ |
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Main Authors: | , , , , , , , , , , , , , , , , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
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BMJ Publishing Group
2016
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Online Access: | https://hdl.handle.net/10037/10526 https://doi.org/10.1136/bmj.i4205 |
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ftunivtroemsoe:oai:munin.uit.no:10037/10526 |
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Open Polar |
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University of Tromsø: Munin Open Research Archive |
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language |
English |
topic |
VDP::Medisinske Fag: 700::Klinisk medisinske fag: 750 VDP::Medical disciplines: 700::Clinical medical disciplines: 750 Betennelse og immunsystem: Medisinsk utstyr Inflammatory and Immune System: Medical devices |
spellingShingle |
VDP::Medisinske Fag: 700::Klinisk medisinske fag: 750 VDP::Medical disciplines: 700::Clinical medical disciplines: 750 Betennelse og immunsystem: Medisinsk utstyr Inflammatory and Immune System: Medical devices Haavardsholm, Espen A. Aga, Anna-Birgitte Olsen, Inge Christoffer Lillegraven, Siri Hammer, Hilde Berner Uhlig, Till Fremstad, Hallvard Madland, Tor Magne Lexberg, Åse Haukeland, Hilde Rødevand, Erik Høili, Christian Stray, Hilde Noraas, Anne Lindtner Hansen, Inger Johanne Widding Bakland, Gunnstein Nordberg, Lena Kristine Bugge Heijde, Desirée van der Kvien, Tore Kristian Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial |
topic_facet |
VDP::Medisinske Fag: 700::Klinisk medisinske fag: 750 VDP::Medical disciplines: 700::Clinical medical disciplines: 750 Betennelse og immunsystem: Medisinsk utstyr Inflammatory and Immune System: Medical devices |
description |
Published version. Source at http://dx.doi.org/10.1136/bmj.i4205 Objective: To determine whether a treatment strategy based on structured ultrasound assessment would lead to improved outcomes in rheumatoid arthritis, compared with a conventional strategy. Design: Multicentre, open label, two arm, parallel group, randomised controlled strategy trial. Setting: Ten rheumatology departments and one specialist centre in Norway, from September 2010 to September 2015. Participants: 238 patients were recruited between September 2010 and April 2013, of which 230 (141 (61%) female) received the allocated intervention and were analysed for the primary outcome. The main inclusion criteria were age 18-75 years, fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis, disease modifying anti-rheumatic drug naivety with indication for disease modifying drug therapy, and time from first patient reported swollen joint less than two years. Patients with abnormal kidney or liver function or major comorbidities were excluded. Interventions: 122 patients were randomised to an ultrasound tight control strategy targeting clinical and imaging remission, and 116 patients were randomised to a conventional tight control strategy targeting clinical remission. Patients in both arms were treated according to the same disease modifying anti-rheumatic drug escalation strategy, with 13 visits over two years. Main outcome measures: The primary endpoint was the proportion of patients with a combination between 16 and 24 months of clinical remission, no swollen joints, and nonprogression of radiographic joint damage. Secondary outcomes included measures of disease activity, radiographic progression, functioning, quality of life, and adverse events. All participants who attended at least one follow-up visit were included in the full analysis set. Results: 26 (22%) of the 118 analysed patients in the ultrasound tight control arm and 21 (19%) of the 112 analysed patients in the clinical tight control arm reached the primary endpoint (mean difference 3.3%, 95% confidence interval −7.1% to 13.7%). Secondary endpoints (disease activity, physical function, and joint damage) were similar between the two groups. Six (5%) patients in the ultrasound tight control arm and seven (6%) patients in the conventional arm had serious adverse events. Conclusions: The systematic use of ultrasound in the follow-up of patients with early rheumatoid arthritis treated according to current recommendations is not justified on the basis of the ARCTIC results. The findings highlight the need for randomised trials assessing the clinical application of medical technology. |
format |
Article in Journal/Newspaper |
author |
Haavardsholm, Espen A. Aga, Anna-Birgitte Olsen, Inge Christoffer Lillegraven, Siri Hammer, Hilde Berner Uhlig, Till Fremstad, Hallvard Madland, Tor Magne Lexberg, Åse Haukeland, Hilde Rødevand, Erik Høili, Christian Stray, Hilde Noraas, Anne Lindtner Hansen, Inger Johanne Widding Bakland, Gunnstein Nordberg, Lena Kristine Bugge Heijde, Desirée van der Kvien, Tore Kristian |
author_facet |
Haavardsholm, Espen A. Aga, Anna-Birgitte Olsen, Inge Christoffer Lillegraven, Siri Hammer, Hilde Berner Uhlig, Till Fremstad, Hallvard Madland, Tor Magne Lexberg, Åse Haukeland, Hilde Rødevand, Erik Høili, Christian Stray, Hilde Noraas, Anne Lindtner Hansen, Inger Johanne Widding Bakland, Gunnstein Nordberg, Lena Kristine Bugge Heijde, Desirée van der Kvien, Tore Kristian |
author_sort |
Haavardsholm, Espen A. |
title |
Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial |
title_short |
Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial |
title_full |
Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial |
title_fullStr |
Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial |
title_full_unstemmed |
Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial |
title_sort |
ultrasound in management of rheumatoid arthritis: arctic randomised controlled strategy trial |
publisher |
BMJ Publishing Group |
publishDate |
2016 |
url |
https://hdl.handle.net/10037/10526 https://doi.org/10.1136/bmj.i4205 |
geographic |
Arctic Norway |
geographic_facet |
Arctic Norway |
genre |
Arctic Arctic |
genre_facet |
Arctic Arctic |
op_relation |
BMJ (British Medical Journal) Haavardsholm EA. et.al.: Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial. BMJ (British Medical Journal). 2016;354 FRIDAID 1447961 doi:10.1136/bmj.i4205 0959-8146 0959-535X https://hdl.handle.net/10037/10526 |
op_rights |
openAccess |
op_doi |
https://doi.org/10.1136/bmj.i4205 |
container_title |
BMJ |
container_start_page |
i4205 |
_version_ |
1766296624475144192 |
spelling |
ftunivtroemsoe:oai:munin.uit.no:10037/10526 2023-05-15T14:24:10+02:00 Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial Haavardsholm, Espen A. Aga, Anna-Birgitte Olsen, Inge Christoffer Lillegraven, Siri Hammer, Hilde Berner Uhlig, Till Fremstad, Hallvard Madland, Tor Magne Lexberg, Åse Haukeland, Hilde Rødevand, Erik Høili, Christian Stray, Hilde Noraas, Anne Lindtner Hansen, Inger Johanne Widding Bakland, Gunnstein Nordberg, Lena Kristine Bugge Heijde, Desirée van der Kvien, Tore Kristian 2016-08-16 https://hdl.handle.net/10037/10526 https://doi.org/10.1136/bmj.i4205 eng eng BMJ Publishing Group BMJ (British Medical Journal) Haavardsholm EA. et.al.: Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial. BMJ (British Medical Journal). 2016;354 FRIDAID 1447961 doi:10.1136/bmj.i4205 0959-8146 0959-535X https://hdl.handle.net/10037/10526 openAccess VDP::Medisinske Fag: 700::Klinisk medisinske fag: 750 VDP::Medical disciplines: 700::Clinical medical disciplines: 750 Betennelse og immunsystem: Medisinsk utstyr Inflammatory and Immune System: Medical devices Journal article Tidsskriftartikkel Peer reviewed 2016 ftunivtroemsoe https://doi.org/10.1136/bmj.i4205 2021-06-25T17:55:10Z Published version. Source at http://dx.doi.org/10.1136/bmj.i4205 Objective: To determine whether a treatment strategy based on structured ultrasound assessment would lead to improved outcomes in rheumatoid arthritis, compared with a conventional strategy. Design: Multicentre, open label, two arm, parallel group, randomised controlled strategy trial. Setting: Ten rheumatology departments and one specialist centre in Norway, from September 2010 to September 2015. Participants: 238 patients were recruited between September 2010 and April 2013, of which 230 (141 (61%) female) received the allocated intervention and were analysed for the primary outcome. The main inclusion criteria were age 18-75 years, fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis, disease modifying anti-rheumatic drug naivety with indication for disease modifying drug therapy, and time from first patient reported swollen joint less than two years. Patients with abnormal kidney or liver function or major comorbidities were excluded. Interventions: 122 patients were randomised to an ultrasound tight control strategy targeting clinical and imaging remission, and 116 patients were randomised to a conventional tight control strategy targeting clinical remission. Patients in both arms were treated according to the same disease modifying anti-rheumatic drug escalation strategy, with 13 visits over two years. Main outcome measures: The primary endpoint was the proportion of patients with a combination between 16 and 24 months of clinical remission, no swollen joints, and nonprogression of radiographic joint damage. Secondary outcomes included measures of disease activity, radiographic progression, functioning, quality of life, and adverse events. All participants who attended at least one follow-up visit were included in the full analysis set. Results: 26 (22%) of the 118 analysed patients in the ultrasound tight control arm and 21 (19%) of the 112 analysed patients in the clinical tight control arm reached the primary endpoint (mean difference 3.3%, 95% confidence interval −7.1% to 13.7%). Secondary endpoints (disease activity, physical function, and joint damage) were similar between the two groups. Six (5%) patients in the ultrasound tight control arm and seven (6%) patients in the conventional arm had serious adverse events. Conclusions: The systematic use of ultrasound in the follow-up of patients with early rheumatoid arthritis treated according to current recommendations is not justified on the basis of the ARCTIC results. The findings highlight the need for randomised trials assessing the clinical application of medical technology. Article in Journal/Newspaper Arctic Arctic University of Tromsø: Munin Open Research Archive Arctic Norway BMJ i4205 |