Outcome Variables for Osteoarthritis Clinical Trials: The OMERACT-OARSI Set of Responder Criteria

THAO PHAM, DÉSIRÉE VAN DER HEIJDE, MARISSA LASSERE, ROY D. ALTMAN, JENNIFER J. ANDERSON, NICHOLAS BELLAMY, MARC HOCHBERG, LEE SIMON, VIBEKE STRAND, THASIA WOODWORTH, and MAXIME DOUGADOS

ABSTRACT.

Improvement in analysis and reporting results of osteoarthritis (OA) clinical trials has been recently obtained because of harmonization and standardization of the selection of outcome variables (OMERACT 3 and OARSI). Moreover, OARSI has recently proposed the OARSI responder criteria. This composite index permits presentation of results of symptom modifying clinical trials in OA based on individual patient responses (responder yes/no). The 2 organizations (OMERACT and OARSI) established a task force aimed at evaluating: (1) the variability of observed placebo and active treatment effects using the OARSI responder criteria; and (2) the possibility of proposing a simplified set of criteria. The conclusions of the task force were presented and discussed during the OMERACT 6 conference, where a simplified set of responder criteria (OMERACT-OARSI set of criteria) was proposed. (J Rheumatol 2003;30:1648-54)

Key Indexing Terms:

OSTEOARTHRITIS
OUTCOMES
CLINICAL RESPONDER CRITERIA

---

From René Descartes University, AP-HP, Rheumatology B Department, Cochin Hospital, Paris, France.

T. Pham, MD, René Descartes University, Cochin Hospital; Aix-Marseille II University, Conception Hospital, Marseille, France; D. van der Heijde, MD, PhD, Professor, Department of Rheumatology, University Hospital and Biomedical Research Institute, Maastricht, The Netherlands; M.N.D. Lassere, MB, BS, PhD, FRACP, FAFPHM, Staff Specialist in Rheumatology, Department of Rheumatology, St. George Hospital, University of NSW, Sydney, Australia; R.D. Altman, MD, University of Miami, Department of Veterans Affairs Medical Center, Miami, FL; J.J. Anderson, PhD, Clinical Epidemiology Research and Training Unit, Boston Medical Center, Boston, MA, USA; N. Bellamy, MD, MSc, FACP, FRCP, FRCPC, FAFRM, FRACP, Department of Medicine, University of Queensland, Royal Brisbane Hospital, Queensland, Australia; M. Hochberg, MD, MPH, Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD; L. Simon, MD, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA; V. Strand, MD, Biopharmaceutical Consultant, Portola Valley, CA; T. Woodworth, Pfizer Global Research and Development, New London, CT, USA; M. Dougados, MD, René Descartes University, Cochin Hospital, Paris, France.

Address reprint requests to Dr. M. Dougados, Rheumatology B Department, Cochin Hospital, 27 rue du Faubourg Saint Jacques, 75014 Paris, France.

---