EULAR recommendations for points to consider in conducting clinical trials in systemic lupus erythematosus (SLE)

C Gordon ^1*, G K Bertsias ², J P. A. Ioannidis ³, J Boletis ⁴, S Bombardieri ⁵, R Cervera ⁶, C Dostál ⁷, G Font ⁶, I-M Gilboe ⁸, F Houssiau ⁹, T WJ Huizinga ¹⁰, D Isenberg ¹¹, C G.M. Kallenberg ¹², M A Khamashta ¹³, J-C Piette ¹⁴, M Schneider ¹⁵, J S Smolen ¹⁶, G Sturfelt ¹⁷, A Tincani ¹⁸, R Van Vollenhoven ¹⁹ and D T Boumpas ²

¹ Birmingham University Medical School, United Kingdom
² University of Crete, Greece
³ Clinical Trials and Evidence-Based Medicine Unit, Department of Hygiene and Epidemiology, University, 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, Czech Republic
⁸ Department of Rheumatology, Rikshospitalet, Oslo, Norway
⁹ Department of Rheumatology, Cliniques Universitaires Saint-Luc, Belgium
¹⁰ Department of Rheumatology Leiden University Medical Center, Leiden, Netherlands
¹¹ Centre for Rheumatology, University College London Hospitals, London, United Kingdom
¹² University Medical Center Groningen, Netherlands
¹³ Lupus Research Unit, The Rayne Institute, St Thomas' Hospital, London, United Kingdom
¹⁴ Service de Médecine Interne, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
¹⁵ Rheumatolology, Clinic of Endocrinology, Diabetology and Rheumatology, Heinrich-Heine-University, Germany
¹⁶ University of Vienna, Austria
¹⁷ University of Lund, Sweden
¹⁸ Rheumatologia e Immunologia Clinica, Ospedale Civile di Brescia, Italy
¹⁹ Rheumatology Unit, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Sweden

^* To whom correspondence should be addressed. E-mail: p.c.gordon{at}bham.ac.uk.

Accepted 21 March 2008

Abstract

Objective: 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.

Conclusion: 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 disemminated, 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.