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EULAR recommendations for points to consider in conducting clinical trials in systemic lupus erythematosus (SLE)
  1. C Gordon (p.c.gordon{at}bham.ac.uk)
  1. Birmingham University Medical School, United Kingdom
    1. G K Bertsias (gbert{at}med.uoc.gr)
    1. University of Crete, Greece
      1. J P. A. Ioannidis (jioannid{at}cc.uoi.gr)
      1. Clinical Trials and Evidence-Based Medicine Unit, Department of Hygiene and Epidemiology, University, Greece
        1. J Boletis (laikneph{at}laiko.gr)
        1. Department of Nephrology and Transplantation Medicine, Laiko Hospital, Athens, Greece
          1. S Bombardieri (bombardieri{at}clinexprheumatol.org)
          1. Cattedra di Reumatologia, Universita di Pisa, Pisa, Italy
            1. R Cervera (rcervera{at}clinic.ub.es)
            1. Department of Autoimmune Diseases, Hospital Clínic, Barcelona, Catalonia, Spain
              1. C Dostál (dost{at}revma.cz)
              1. Institute of Rheumatology, Czech Republic
                1. G Font
                1. Department of Autoimmune Diseases, Hospital Clínic, Barcelona, Catalonia, Spain
                  1. I-M Gilboe (inge-margrethe.gilboe{at}rikshospitalet.no)
                  1. Department of Rheumatology, Rikshospitalet, Oslo, Norway
                    1. F Houssiau (frederic.houssiau{at}ruma.ucl.ac.be)
                    1. Department of Rheumatology, Cliniques Universitaires Saint-Luc, Belgium
                      1. T WJ Huizinga (t.w.j.huizinga{at}lumc.nl)
                      1. Department of Rheumatology Leiden University Medical Center, Leiden, Netherlands
                        1. D Isenberg
                        1. Centre for Rheumatology, University College London Hospitals, London, United Kingdom
                          1. C G.M. Kallenberg (c.g.m.kallenberg{at}int.umcg.nl)
                          1. University Medical Center Groningen, Netherlands
                            1. M A Khamashta (munther.khamashta{at}kcl.ac.uk)
                            1. Lupus Research Unit, The Rayne Institute, St Thomas' Hospital, London, United Kingdom
                              1. J-C Piette (jcpiette{at}free.fr)
                              1. Service de Médecine Interne, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
                                1. M Schneider (schneider{at}rheumanet.org)
                                1. Rheumatolology, Clinic of Endocrinology, Diabetology and Rheumatology, Heinrich-Heine-University, Germany
                                  1. J S Smolen (josef.smolen{at}wienkav.at)
                                  1. University of Vienna, Austria
                                    1. G Sturfelt (gunnar.sturfelt{at}reum.lu.se)
                                    1. University of Lund, Sweden
                                      1. A Tincani (tincani{at}spedalicivili.brescia.it)
                                      1. Rheumatologia e Immunologia Clinica, Ospedale Civile di Brescia, Italy
                                        1. R Van Vollenhoven (ronald.vanvollenhoven{at}karolinska.se)
                                        1. Rheumatology Unit, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Sweden
                                          1. D T Boumpas (boumpasd{at}med.uoc.gr)
                                          1. University of Crete, Greece

                                            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.

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