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Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations
  1. D Aletaha1,
  2. R Landewe2,
  3. T Karonitsch1,
  4. J Bathon3,
  5. M Boers4,
  6. C Bombardier5,
  7. S Bombardieri6,
  8. H Choi7,
  9. B Combe8,
  10. M Dougados9,
  11. P Emery10,
  12. J Gomez-Reino11,
  13. E Keystone12,
  14. G Koch13,
  15. T K Kvien14,
  16. E Martin-Mola15,
  17. M Matucci-Cerinic16,
  18. K Michaud17,
  19. J O’Dell17,
  20. H Paulus18,
  21. T Pincus19,
  22. P Richards20,
  23. L Simon21,
  24. J Siegel22,
  25. J S Smolen1,23,
  26. T Sokka24,
  27. V Strand25,
  28. P Tugwell26,
  29. D van der Heijde27,
  30. P van Riel28,
  31. S Vlad29,
  32. R van Vollenhoven30,
  33. M Ward31,
  34. M Weinblatt32,
  35. G Wells33,
  36. B White34,
  37. F Wolfe35,
  38. B Zhang29,
  39. A Zink36,
  40. D Felson29
  1. 1
    Medical University of Vienna, Vienna, Austria
  2. 2
    University Hospital Maastricht, Maastricht, The Netherlands
  3. 3
    Johns Hopkins University, Baltimore, Maryland, USA
  4. 4
    VU University Medical Center, Amsterdam, The Netherlands
  5. 5
    Institute for Work and Health, Toronto, Ontario, Canada
  6. 6
    University of Pisa, Pisa, Italy
  7. 7
    University of British Columbia, Vancouver, British Columbia, Canada
  8. 8
    CHU de Montpellier, Montpellier, France
  9. 9
    Paris-Descartes University, Paris, France
  10. 10
    University of Leeds, Leeds, UK
  11. 11
    University of Santiago de Compostela School of Medicine, Santiago, Spain
  12. 12
    University of Toronto, Ontario, Canada
  13. 13
    University of North Carolina, Chapel Hill, North Carolina, USA
  14. 14
    Diakonhjemmet Hospital, Oslo, Norway
  15. 15
    Hospital Universitario La Paz, Madrid, Spain
  16. 16
    University of Florence, Florence, Italy
  17. 17
    University of Nebraska, Omaha, Nebraska, USA
  18. 18
    University of California, Los Angeles, California, USA
  19. 19
    New York University Hospital for Joint Diseases, New York, USA
  20. 20
    University of Bristol, Bristol, UK
  21. 21
    Beth Israel Deaconess Medical, Boston, Massachusetts, USA
  22. 22
    Food and Drug Administration, Rockville, Maryland, USA
  23. 23
    Hietzing Hospital, Vienna, Austria
  24. 24
    Jyvaskyla Central Hospital, Jyvaskyla, Finland
  25. 25
    Stanford University, Portola Valley, California, USA
  26. 26
    Institute of Population Health, Ottawa, Ontario, Canada
  27. 27
    Leiden University Medical Center, Leiden, The Netherlands
  28. 28
    Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
  29. 29
    Boston University School of Medicine, Boston, Massachusetts, USA
  30. 30
    Karolinska University Hospital, Stockholm, Sweden
  31. 31
    National Institutes of Health, Bethesda, Maryland, USA
  32. 32
    Brigham & Women’s Hospital, Boston, Massachusetts, USA
  33. 33
    University of Ottawa, Ottawa, Ontario, Canada
  34. 34
    Medimmune, Gaithersburg, Maryland, USA
  35. 35
    National Data Bank for Rheumatic Diseases, Wichita, Kansas, USA
  36. 36
    Charité Medical School, Berlin, Germany
  1. D Aletaha, Division of Rheumatology, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria; daniel.aletaha{at}meduniwien.ac.at

Abstract

Objective: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).

Methods: The project followed the EULAR standardised operating procedures, which use a three-step approach: (1) expert-based definition of relevant research questions (November 2006); (2) systematic literature search (November 2006 to May 2007); and (3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007).

Results: Eleven relevant questions were identified for the literature search. Based on the evidence from the literature the expert panel recommended that each trial should report the following items: (1) disease activity response and disease activity states; (2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; (3) baseline disease activity levels (in general); (4) the percentage of patients achieving a low disease activity state and remission; (5) time to onset of the primary outcome; (6) sustainability of the primary outcome; (7) fatigue.

Conclusions: These recommendations endorsed by EULAR and ACR will help harmonise the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.

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Footnotes

  • Funding: This project was fully funded by EULAR and the ACR.

  • Competing interests: None.

  • The views presented in this presentation do not necessarily reflect those of the Food and Drug Administration or the National Institutes of Health.

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