The 'Switch’ study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug

BMC Musculoskeletal Disorders

Maya H Buch⁴  Sue Pavitt⁵  Linda D Sharples³  David Scott⁷  Catherine Reynolds³  Anthony Redmond⁴  Christopher McCabe²  Anne-Maree Keenan⁴  Claire Hulme⁶  Suzanne Hartley³  Janine C Gray³  Catherine Fernandez³  Colin C Everett³  Paul Emery⁴  Claire T Davies³  Ailsa Bosworth¹  Sarah Brown³  Nuria C Navarro Coy⁴ 

[1] National Rheumatoid Arthritis Society (NRAS), Maidenhead, Berkshire SL6 3RT, UK;University of Alberta, 112 Street NW, Edmonton, Alberta, Canada;Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK;NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds Teaching Hospitals Trust, Leeds LS7 4SA, UK;Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK;Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK;School of Medicine, University of East Anglia, Norfolk NR4 7QN, UK

关键词: Cost-effectiveness;    Randomised clinical trial;    Biologics;    Non-responder;    Abatacept;    Rituximab;    TNF-inhibitor;    Rheumatoid arthritis;   

Others  :  1118629
DOI  :  10.1186/1471-2474-15-452

 received in 2014-12-09, accepted in 2014-12-17,  发布年份 2014

【 摘 要 】

Background

Rheumatoid Arthritis (RA) is one of the most common autoimmune diseases, affecting approximately 1% of the UK adult population. Patients suffer considerable pain, stiffness and swelling and can sustain various degrees of joint destruction, deformity, and significant functional decline. In addition, the economic burden due to hospitalisation and loss of employment is considerable, with over 50% of patients being work-disabled within 10 years of diagnosis. Despite several biologic disease modifying anti-rheumatic drugs (bDMARD) now available, there is a lack of data to guide biologic sequencing. In the UK, second-line biologic treatment is restricted to a single option, rituximab. The aim of the SWITCH trial is to establish whether an alternative-mechanism-TNF-inhibitor (TNFi) or abatacept are as effective as rituximab in patients with RA who have failed an initial TNFi drug.

Methods/Design

SWITCH is a pragmatic, phase IV, multi-centre, parallel-group design, open-label, randomised, controlled trial (RCT) comparing alternative-mechanism-TNFi and abatacept with rituximab in patients with RA who have failed an initial TNFi drug. Participants are randomised in a 1:1:1 ratio to receive alternative mechanism TNFi, (monoclonal antibodies: infliximab, adalimumab, certolizumab or golimumab or the receptor fusion protein, etanercept), abatacept or rituximab during the interventional phase (from randomisation up to week 48). Participants are subsequently followed up to a maximum of 96 weeks, which constitutes the observational phase. The primary objective is to establish whether an alternative-mechanism-TNFi or abatacept are non-inferior to rituximab in terms of disease response at 24 weeks post randomisation. The secondary objectives include the comparison of alternative-mechanism-TNFi and abatacept to rituximab in terms of disease response, quality of life, toxicity, safety and structural and bone density outcomes over a 12-month period (48 weeks) and to evaluate the cost-effectiveness of switching patients to alternative active therapies compared to current practice.

Discussion

SWITCH is a well-designed trial in this therapeutic area that aims to develop a rational treatment algorithm to potentially inform personalised treatment regimens (as opposed to switching all patients to only one available (and possibly unsuccessful) therapy), which may lead to long-term improved patient outcomes and gains in population health.

Trial registration

UKCRN Portfolio ID: 12343;ISRCTN89222125;NCT01295151

【 授权许可】

   
2015 Navarro Coy et al.; licensee BioMed Central.

【 图 表 】

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