The TICOPA protocol (TIght COntrol of Psoriatic Arthritis): a randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis

BMC Musculoskeletal Disorders

Philip S Helliwell⁴  Philip G Conaghan⁶  Paul Emery⁶  Claire Hulme⁵  Sue Pavitt³  Anna Moverley⁴  Jennifer Law²  Emma Skinner¹  Howard Collier²  Lucy McParland²  Sarah Brown²  Sarah R Brown²  Nuria Navarro-Coy²  Laura C Coates⁴ 

[1] Arthritis Research UK Primary Care Centre, Primary Care Services, University of Keele, Staffordshire ST5 5BG, UK;Clinical Trials Research Unit, Leeds Institute of Molecular Medicine, University of Leeds, Leeds LS2 9JT, UK;Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK;Division of Rheumatic and Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds LS7 4SA, UK;Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK;NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds LS7 4SA, UK

关键词: Standard care;    Intensive management;    Tight control;    Tight management;    Early psoriatic arthritis;    Psoriatic arthritis;   

Others  :  1133256
DOI  :  10.1186/1471-2474-14-101

 received in 2013-02-11, accepted in 2013-02-28,  发布年份 2013

【 摘 要 】

Background

Psoriatic Arthritis (PsA) is estimated to occur in 10-15% of people with psoriasis and accounts for 13% of people attending early arthritis clinics. With an increasing awareness of the poor outcomes associated with PsA and the availability of new effective, but costly, treatments, there is an urgent need to research the optimal treatment for patients with PsA. The aim of the TICOPA study is to establish whether, in treatment naive early PsA patients, “tight control” intensive management with protocol driven therapies and pre-defined objective targets for treatment can improve clinical outcome compared to standard care alone.

Methods/design

TICOPA is a UK multicentre, open-label, randomised controlled, parallel group trial of 206 patients with early PsA. Patients will be randomised on a 1:1 basis to receive either standard care (12 weekly review) or intensive management (4 weekly review) for a period of 48 weeks. Patients assigned to the intensive management group will follow a strict treatment protocol whereby dose continuation/escalation is determined through the objective assessment of the minimal disease activity (MDA) criteria. Patients assigned to the standard care group will have treatment prescribed as felt appropriate by the treating clinician, with no set protocol. The primary objective of the trial is to compare intensive management with standard care in terms of the proportion of patients achieving an ACR 20 response at 48 weeks post-randomisation, in order to determine whether intensive management has superior clinical efficacy. Key secondary outcomes include ACR 50 and 70, PASI 75 and X-ray Van der Heijde score at 48 weeks post-randomisation along with cost-effectiveness at 12, 24 and 28 weeks.

Discussion

The TICOPA trial will provide direct evidence as to whether the use of early and intensive treatment in PsA in routine clinical care leads to an improvement in patients’ disease activity and a reduction in radiological joint damage.

Trial registration

ISRCTN30147736, NCT01106079

【 授权许可】

   
2013 Coates et al.; licensee BioMed Central Ltd.

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