RECOMMENDATIONS

EULAR points to consider for conducting clinical trials in systemic lupus erythematosus

C Gordon¹, G Bertsias², J P A Ioannidis³, J Boletis⁴, S Bombardieri⁵, R Cervera⁶, C Dostál⁷, J Font⁶, I-M Gilboe⁸, F Houssiau⁹, T W J Huizinga¹⁰, D Isenberg¹¹, C G M Kallenberg¹², M A Khamashta¹³, J-C Piette¹⁴, M Schneider¹⁵, J S Smolen¹⁶, G Sturfelt¹⁷, A Tincani¹⁸, R Van Vollenhoven¹⁹, D T Boumpas²

¹ Rheumatology Research Group, Division of Immunity and Infection, The University of Birmingham, Birmingham, UK
² Internal Medicine, and Rheumatology, Clinical Immunology and Allergy, University of Crete School of Medicine, Heraklion, Greece
³ Clinical Trials and Evidence-Based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece
⁴ Department of Nephrology and Transplantation Medicine, Laiko Hospital, Athens, Greece
⁵ Cattedra di Reumatologia, Universita di Pisa, Pisa, Italy
⁶ Department of Autoimmune Diseases, Hospital Clínic, Barcelona, Catalonia, Spain
⁷ Institute of Rheumatology, Prague, Czech Republic
⁸ Department of Rheumatology, Rikshospitalet, Oslo, Norway
⁹ Rheumatology Department, Université catholique de Louvain, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium
¹⁰ Department of Rheumatology Leiden University Medical Center, Leiden, The Netherlands
¹¹ Centre for Rheumatology, University College London Hospitals, London, UK
¹² Department of Clinical Immunology, University Medical Center Groningen, Groningen, The Netherlands
¹³ Lupus Research Unit, The Rayne Institute, St Thomas’ Hospital, London, UK
¹⁴ Service de Médecine Interne, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
¹⁵ Rheumatolology, Clinic of Endocrinology, Diabetology and Rheumatology, Heinrich-Heine-University, Duesseldorf, Germany
¹⁶ Department of Rheumatology, Medical University of Vienna, Austria
¹⁷ Department of Rheumatology, University Hospital of Lund, Lund, Sweden
¹⁸ Rheumatologia e Immunologia Clinica, Ospedale Civile di Brescia, Italy
¹⁹ Rheumatology Unit, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Solna, Sweden

Professor Caroline Gordon, Rheumatology (East Wing), Division of Immunity and Infection, The Medical School, University of Birmingham, Vincent Drive, Edgbaston, Birmingham B15 2TT, UK; p.c.gordon{at}bham.ac.uk

Objective: Systemic lupus erythematosus (SLE) is a complex multi-organ disease, characterised by relapses and remissions. Designing a high-quality randomised controlled trial poses many challenges. We have developed evidenced-based recommendations for points to consider in conducting clinical trials in patients with SLE.

Methods: The EULAR Task Force on SLE comprised 19 specialists and a clinical epidemiologist. Initially, the evidence for clinical trial end-points in SLE was evaluated and this has been reported separately. A consensus approach was developed by the SLE Task Force in formulating recommendations for points to consider when conducting clinical trials in SLE.

Results: The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not actually been validated in clinical trials, although other forms of validation have been undertaken. The final recommendations for points to consider for conducting clinical trials in SLE address the following areas: study design, eligibility criteria, outcome measures including adverse events, concomitant therapies for SLE and its complications.

Conclusions: Recommendations for points to consider when conducting clinical trials in SLE were developed using an evidence-based approach followed by expert consensus. The recommendations should be disseminated, implemented and then reviewed in detail and revised using an evidence-based approach in about 5 years, by which time there will be further evidence to consider from current clinical trials.

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This article has been cited by other articles:

• Bertsias, G K, Ioannidis, J P A, Boletis, J, Bombardieri, S, Cervera, R, Dostal, C, Font, J, Gilboe, I M, Houssiau, F, Huizinga, T, Isenberg, D, Kallenberg, C G M, Khamashta, M, Piette, J C, Schneider, M, Smolen, J, Sturfelt, G, Tincani, A, van Vollenhoven, R, Boumpas, D T, Gordon, C (2009). EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints. Ann Rheum Dis 68: 477-483 [Abstract] [Full Text]