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Ann Rheum Dis 68:477-483 doi:10.1136/ard.2007.083030
  • Recommendations

EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints

  1. G K Bertsias1,
  2. J P A Ioannidis2,
  3. J Boletis3,
  4. S Bombardieri4,
  5. R Cervera5,
  6. C Dostal6,
  7. J Font5,
  8. I M Gilboe7,
  9. F Houssiau8,
  10. T Huizinga9,
  11. D Isenberg10,
  12. C G M Kallenberg11,
  13. M Khamashta12,
  14. J C Piette13,
  15. M Schneider14,
  16. J Smolen15,
  17. G Sturfelt16,
  18. A Tincani17,
  19. R van Vollenhoven18,
  20. D T Boumpas1,
  21. C Gordon19
  1. 1
    Internal Medicine, and Rheumatology, Clinical Immunology and Allergy, University of Crete School of Medicine, Heraklion, Greece
  2. 2
    Clinical Trials and Evidence-Based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece
  3. 3
    Department of Nephrology and Transplantation Medicine, Laiko Hospital, Athens, Greece
  4. 4
    Cattedra di Reumatologia, Universita di Pisa, Pisa, Italy
  5. 5
    Department of Autoimmune Diseases, Hospital Clínic, Barcelona, Catalonia, Spain
  6. 6
    Institute of Rheumatology, Prague, Czech Republic
  7. 7
    Department of Rheumatology, Rikshospitalet, Oslo, Norway
  8. 8
    Rheumatology Department, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium
  9. 9
    Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  10. 10
    Centre for Rheumatology, University College London Hospitals, London, UK
  11. 11
    Department of Clinical Immunology, University Medical Center Groningen, Groningen, The Netherlands
  12. 12
    Lupus Research Unit, The Rayne Institute, St Thomas’ Hospital, London, UK
  13. 13
    Service de Médecine Interne, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
  14. 14
    Rheumatolology, Clinic of Endocrinology, Diabetology and Rheumatology, Heinrich-Heine-University, Düsseldorf, Germany
  15. 15
    Department of Rheumatology, Medical University of Vienna, Vienna, Austria
  16. 16
    Department of Rheumatology, University Hospital of Lund, Lund, Sweden
  17. 17
    Rheumatologia e Immunologia Clinica, Ospedale Civile di Brescia, Brescia, Italy
  18. 18
    Rheumatology Unit, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Solna, Sweden
  19. 19
    Rheumatology Research Group, Division of Immunity and Infection, The University of Birmingham, Birmingham, UK
  1. Professor C 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
  • Accepted 7 April 2008
  • Published Online First 23 April 2008

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 European League Against Rheumatism (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 the PubMed and Cochrane Library databases was performed using McMaster/Hedges clinical query strategies and an array of relevant terms. Evidence was categorised 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.

Footnotes

  • Competing interests: None declared.

  • Funding: Support for this work was provided via a grant from the EULAR Executive Committee.