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Open Access Highly Accessed Study protocol

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

Laura C Coates1*, Nuria Navarro-Coy12, Sarah R Brown2, Sarah Brown2, Lucy McParland2, Howard Collier2, Emma Skinner26, Jennifer Law2, Anna Moverley1, Sue Pavitt3, Claire Hulme4, Paul Emery15, Philip G Conaghan15 and Philip S Helliwell1

Author Affiliations

1 Division of Rheumatic and Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds LS7 4SA, UK

2 Clinical Trials Research Unit, Leeds Institute of Molecular Medicine, University of Leeds, Leeds LS2 9JT, UK

3 Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK

4 Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK

5 NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds LS7 4SA, UK

6 Arthritis Research UK Primary Care Centre, Primary Care Services, University of Keele, Staffordshire ST5 5BG, UK

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BMC Musculoskeletal Disorders 2013, 14:101  doi:10.1186/1471-2474-14-101

Published: 21 March 2013

Abstract

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

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