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Evidence for selection of end-points for clinical trials in systemic lupus erytematosus (SLE): a systematic literature review. Report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT)
  1. G K Bertsias (gbert{at}med.uoc.gr)
  1. University of Crete, Greece
    1. J PA Ioannidis (jioannid{at}cc.uoi.gr)
    1. University, Greece
      1. J Boletis (laikneph{at}laiko.gr)
      1. Department of Nephrology and Transplantation Medicine, Laiko Hospital, Greece
        1. S Bombardieri (bombardieri{at}clinexprheumatol.org)
        1. Cattedra di Reumatologia, Universita di Pisa, Italy
          1. R Cervera (rcervera{at}clinic.ub.es)
          1. Department of Autoimmune Diseases, Hospital Clínic, Spain
            1. C Dostál (dost{at}revma.cz)
            1. Institute of Rheumatology, Czech Republic
              1. J Font
              1. Department of Autoimmune Diseases, Hospital Clínic, Spain
                1. I-M Gilboe (inge-margrethe.gilboe{at}rikshospitalet.no)
                1. Department of Rheumatology, Rikshospitalet, Norway
                  1. F Houssiau (frederic.houssiau{at}uclouvain.be)
                  1. Rheumatology Department, Université catholique de Louvain, Cliniques Universitaires Saint-Luc, Belgium
                    1. T WJ Huizinga (t.w.j.huizinga{at}lumc.nl)
                    1. Department of Rheumatology, Netherlands
                      1. D Isenberg
                      1. Centre for Rheumatology, University College London Hospitals, United Kingdom
                        1. C GM 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, United Kingdom
                            1. J-C Piette (jcpiette{at}free.fr)
                            1. Service de Médecine Interne, Groupe Hospitalier Pitié-Salpêtrière, 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
                                    1. Rheumatologia e Immunologia Clinica, Ospedale Civile di Brescia, Italy
                                      1. R van Vollenhoven
                                      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
                                          1. C Gordon (p.c.gordon{at}bham.ac.uk)
                                          1. Birmingham University Medical School, United Kingdom

                                            Abstract

                                            Objective: To assess available evidence on the use of end-points (outcome measures) in clinical trials in systemic lupus erythematosus (SLE), as a part of the development of evidence-based recommendations for points to consider in clinical trials in SLE.

                                            Methods: The EULAR Task Force on SLE comprised 19 specialists, a clinical epidemiologist and a research fellow. Key questions addressing the evidence for clinical trial end-points in SLE were compiled using the Delphi technique. A systematic search of PubMed and Cochrane Library was performed using McMaster/Hedges clinical queries' strategies and an array of relevant terms. Evidence was categorized based on sample size and type of design and the categories of available evidence were identified for each recommendation. The strength of recommendation was assessed based on the category of available evidence and agreement on the statements was measured across the 19 specialists.

                                            Results: Eight questions were generated regarding end-points for clinical trials. The evidence to support each proposition was evaluated. The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not been formally validated in clinical trials, although some indirect validation has been undertaken.

                                            Conclusion: This systematic literature review forms the evidence base considered in the development of the EULAR recommendations for end-points in clinical trials in SLE.

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