title: OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.
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.
authors.affiliation: Departments of Rheumatology, Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Kloppenburg
authors.affiliation: Department of Rheumatology, Saint-Antoine Hospital - AP-HP, and Private Office, Paris, France. Electronic address: emaheu@wanadoo.fr.
authors.forename: E
authors.initials: E
authors.lastname: Maheu
authors.affiliation: Duke Molecular Physiology Institute and Division of Rheumatology, Duke University School of Medicine, Durham, NC, USA.
authors.forename: V B
authors.initials: VB
authors.lastname: Kraus
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, 3004, Australia.
authors.forename: F
authors.initials: F
authors.lastname: Cicuttini
authors.affiliation: Division of Rheumatology, Orthopaedics and Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.
authors.forename: M
authors.initials: M
authors.lastname: Doherty
authors.affiliation: Department of Rheumatology, Bichat Hospital, AP-HP, Paris, France.
authors.forename: R-L
authors.initials: RL
authors.lastname: Dreiser
authors.affiliation: 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.
authors.forename: Y
authors.initials: Y
authors.lastname: Henrotin
authors.affiliation: Neurology & Pain Clinical Development, Allergan, Inc., 2525 Dupont Dr., Irvine, CA, 92612, USA.
authors.forename: G-L
authors.initials: GL
authors.lastname: Jiang
authors.affiliation: Hospital for Special Surgery, Weil Cornell Medical School, Division of Rheumatology, New York City, USA.
authors.forename: L
authors.initials: L
authors.lastname: Mandl
authors.affiliation: Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec, Canada. Electronic address: jm@martelpelletier.ca.
authors.forename: J
authors.initials: J
authors.lastname: Martel-Pelletier
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: A E
authors.initials: AE
authors.lastname: Nelson
authors.affiliation: 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.
authors.forename: T
authors.initials: T
authors.lastname: Neogi
authors.affiliation: Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec, Canada. Electronic address: dr@jppelletier.ca.
authors.forename: J-P
authors.initials: JP
authors.lastname: Pelletier
authors.affiliation: Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Punzi
authors.affiliation: Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Ramonda
authors.affiliation: SDG LLC, Cambridge, MA, USA.
authors.forename: L S
authors.initials: LS
authors.lastname: Simon
authors.affiliation: Immunology Development, Global Pharmaceutical R&D, Abbvie, North Chicago, USA.
authors.forename: S
authors.initials: S
authors.lastname: Wang
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D019468:Disease Management; D050823:Hand Joints; D006801:Humans; D010003:Osteoarthritis / Q000628:therapy*; D017410:Practice Guidelines as Topic
keywords: Clinical tools; Clinical trials guidelines; Hand osteoarthritis; Methodology; Radiological assessment; Recommendations osteoarthritis