EDITORIAL

Vasculitis and SLE

Why we need guidelines for clinical trials in vasculitis and systemic lupus erythematosus

Chetan Mukhtyar¹, Dimitrios Boumpas², Caroline Gordon³, Wolfgang Gross⁴, David Jayne⁵, Raashid Luqmani¹

¹ Botnar Research Centre, University of Oxford, Oxford, UK
² Division of Rheumatology, Clinical Immunology and Allergy, University of Crete, Heraklion, Greece
³ Department of Rheumatology, Birmingham University, Birmingham, UK
⁴ Department of Rheumatology, University Hospital of Schleswig-Holstein, Campus Lubeck, Lubeck, Germany
⁵ Department of Nephrology, Addenbrooke’s Hospital, Cambridge, UK

Correspondence to:
Correspondence to:
Dr Raashid Luqmani DM FRCP
FRCP(E), Consultant Rheumatologist/Senior Lecturer, Rheumatology Department, Nuffield Orthopaedic Centre and University of Oxford, Windmill Road, Oxford OX3 7LD, UK; raashid.luqmani@noc.anglox.nhs.uk; raashid.luqmani@noc.anglox.nhs.uk

Accepted 6 February 2007

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See linked article, p 605

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Keywords: clinical trials; lupus erythematosus; systemic; vasculitis

The first 150 words of the full text of this article appear below.

The systemic vasculitides and systemic lupus erythematosus (SLE) are uncommon systemic rheumatic diseases. They have attracted increasing clinical trial activity, for which there is a need for international consensus and guidelines on clinical research methodology. There have been a number of relatively small studies of these diseases. Unfortunately, these have had varying design, outcome and assessment measures, thus it is difficult to interpret the evidence or subject it to a meta-analysis, and this has resulted in considerable uncertainty—for example, in deciding the role and dosing of cyclophosphamide in vasculitis or SLE.^1–4 Standardisation of the methodology for conducting clinical trials facilitates recruitment of patients into larger multicentre studies, which are likely to include non-expert centres, because of the low incidence and prevalence of cases. There is increasing involvement by the pharmaceutical industry in clinical trials of SLE and vasculitis. These companies will also need guidelines on which to . . . [Full text of this article]

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Relevant Article

EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti-neutrophil cytoplasm antibody-associated vasculitis

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