OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis

M Kloppenburg; E Maheu; V B Kraus; F Cicuttini; M Doherty; R-L Dreiser; Y Henrotin; G-L Jiang; L Mandl; J Martel-Pelletier; A E Nelson; T Neogi; J-P Pelletier; L Punzi; R Ramonda; L S Simon; S Wang; OARSI Hand Clinical Trial Recommendations Work Group

doi:10.1016/j.joca.2015.03.007

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis

Osteoarthritis Cartilage. 2015 May;23(5):772-86. doi: 10.1016/j.joca.2015.03.007.

Authors

M Kloppenburg¹, E Maheu², V B Kraus³, F Cicuttini⁴, M Doherty⁵, R-L Dreiser⁶, Y Henrotin⁷, G-L Jiang⁸, L Mandl⁹, J Martel-Pelletier¹⁰, A E Nelson¹¹, T Neogi¹², J-P Pelletier¹³, L Punzi¹⁴, R Ramonda¹⁴, L S Simon¹⁵, S Wang¹⁶; OARSI Hand Clinical Trial Recommendations Work Group

Affiliations

¹ Departments of Rheumatology, Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
² Department of Rheumatology, Saint-Antoine Hospital - AP-HP, and Private Office, Paris, France. Electronic address: emaheu@wanadoo.fr.
³ Duke Molecular Physiology Institute and Division of Rheumatology, Duke University School of Medicine, Durham, NC, USA.
⁴ School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, 3004, Australia.
⁵ Division of Rheumatology, Orthopaedics and Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.
⁶ Department of Rheumatology, Bichat Hospital, AP-HP, Paris, France.
⁷ Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, CHU Sart-Tilman, 4000 Liège and Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Marche-en-Famenne, Belgium.
⁸ Neurology & Pain Clinical Development, Allergan, Inc., 2525 Dupont Dr., Irvine, CA, 92612, USA.
⁹ Hospital for Special Surgery, Weil Cornell Medical School, Division of Rheumatology, New York City, USA.
¹⁰ Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec, Canada. Electronic address: jm@martelpelletier.ca.
¹¹ Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
¹² Section of Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, USA; Section of Rheumatology, Boston University School of Medicine, Boston, USA.
¹³ Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec, Canada. Electronic address: dr@jppelletier.ca.
¹⁴ Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy.
¹⁵ SDG LLC, Cambridge, MA, USA.
¹⁶ Immunology Development, Global Pharmaceutical R&D, Abbvie, North Chicago, USA.

PMID: 25952348
DOI: 10.1016/j.joca.2015.03.007

Abstract

Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much has been done to better understand its clinical course and structural progression. Despite this new knowledge, few therapeutic trials have been conducted in hand OA. The last OARSI recommendations for the conduct of clinical trials in hand OA dates back to 2006. The present recommendations aimed at updating previous recommendations, by incorporating new data. The purpose of this expert opinion, consensus driven exercise is to provide evidence-based guidance on the design, execution and analysis of clinical trials in hand OA, where published evidence is available, supplemented by expert opinion, where evidence is lacking, to perform clinical trials in hand OA, both for symptom and for structure-modification. They indicate core outcome measurement sets for studies in hand OA, and list the methods and instruments that should be used to measure symptoms or structure. For both symptom- and structure-modification, at least pain, physical function, patient global assessment, HR-QoL, joint activity and hand strength should be assessed. In addition, for structure-modification trials, structural progression should be measured by radiographic changes. We also provide a research agenda listing many unsolved issues that seem to most urgently need to be addressed from the perspective of performing "good" clinical trials in hand OA. These updated OARSI recommendations should allow for better standardizing the conduct of clinical trials in hand OA in the next future.

Keywords: Clinical tools; Clinical trials guidelines; Hand osteoarthritis; Methodology; Radiological assessment; Recommendations osteoarthritis.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Clinical Trials as Topic / standards*
Disease Management
Hand Joints*
Humans
Osteoarthritis / therapy*
Practice Guidelines as Topic*