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dc.contributor.authorRombach, Ines
dc.contributor.authorTillett, William
dc.contributor.authorJadon, Deepak
dc.contributor.authorTucker, Laura
dc.contributor.authorWatson, Marion
dc.contributor.authorFrancis, Anne
dc.contributor.authorSinomati, Yvonne
dc.contributor.authorEldridge, Lucy
dc.contributor.authorDritsaki, Melina
dc.contributor.authorDutton, Susan J
dc.contributor.authorAl-Mossawi, Hussein
dc.contributor.authorGullick, Nicola
dc.contributor.authorThompson, Ben
dc.contributor.authorCoates, Laura C
dc.date.accessioned2021-04-12T23:31:35Z
dc.date.available2021-04-12T23:31:35Z
dc.date.issued2021-03-04
dc.identifier.issn1745-6215
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/319780
dc.description.abstractBACKGROUND: The Tight Control of psoriatic arthritis (TICOPA) trial confirmed improved clinical outcomes with a treat to target (T2T) strategy in psoriatic arthritis (PsA). This consisted of 4-weekly review and escalation of 'step up' therapy (single disease modifying therapy (DMARD), combination DMARDs and then biologics) based on remission criteria. Based on this, a T2T approach is supported by European PsA treatment recommendations. However, it is not commonly implemented in routine care primarily due to feasibility and cost concerns. In the TICOPA trial, the same treatment regime was used for all participants regardless of their disease profile. Despite the recognition of PsA as a highly heterogeneous condition, no studies have tailored which drugs are used depending on disease severity. The cohort will establish real world outcomes for the T2T approach in PsA and also form the basis of a trials within cohorts (TWiCs) design to test alternative therapeutic approaches within embedded clinical trials providing an evidence base for treatment strategy in PsA. METHODS: The Multicentre Observational Initiative in Treat to target Outcomes in Psoriatic Arthritis (MONITOR-PsA) cohort will apply a T2T approach within routine care. It will recruit newly diagnosed adult patients with PsA starting systemic therapies. The cohort is observational allowing routine therapeutic care within NHS clinics but a T2T approach will be supported when monitoring treatment within the cohort. Eligible participants will be adults (≥18 years) with active PsA with ≥ 1 tender or swollen joints or enthesis who have not previously had treatment with DMARDs for articular disease. DISCUSSION: This study is the first TWiC designed to support a fully powered randomised drug trial. The results from the observational cohort will be compared with those observed in the TICOPA trial investigating the clinical effectiveness and health care costs of the pragmatic T2T approach. Nested trials will provide definitive RCT evidence establishing the optimal management of PsA within the T2T approach. The TWiCs design allows robust generalizability to routine healthcare, avoids disappointment bias, aids recruitment and in future will allow assessment of longer-term outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03531073 . Retrospectively registered on 21 May 2018.
dc.format.mediumElectronic
dc.languageeng
dc.publisherSpringer Science and Business Media LLC
dc.rightsAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectHumans
dc.subjectArthritis, Psoriatic
dc.subjectAntirheumatic Agents
dc.subjectTreatment Outcome
dc.subjectSeverity of Illness Index
dc.subjectResearch Design
dc.subjectAdult
dc.titleTreating to target in psoriatic arthritis: assessing real-world outcomes and optimising therapeutic strategy for adults with psoriatic arthritis-study protocol for the MONITOR-PsA study, a trials within cohorts study design.
dc.typeArticle
prism.issueIdentifier1
prism.publicationDate2021
prism.publicationNameTrials
prism.startingPage185
prism.volume22
dc.identifier.doi10.17863/CAM.66905
dcterms.dateAccepted2021-02-20
rioxxterms.versionofrecord10.1186/s13063-021-05142-7
rioxxterms.versionVoR
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2021-03-04
dc.contributor.orcidCoates, Laura C [0000-0002-4756-663X]
dc.identifier.eissn1745-6215
rioxxterms.typeJournal Article/Review
cam.issuedOnline2021-03-04


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Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International