Review

. 2018 Aug;48(1):1-8.

doi: 10.1016/j.semarthrit.2017.12.003. Epub 2017 Dec 7.

Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)

Jean-Yves L Reginster¹, Nigel K Arden², Ida K Haugen³, Francois Rannou⁴, Etienne Cavalier⁵, Olivier Bruyère¹, Jaime Branco⁶, Roland Chapurlat⁷, Sabine Collaud Basset⁸, Nasser M Al-Daghri⁹, Elaine M Dennison¹⁰, Gabriel Herrero-Beaumont¹¹, Andrea Laslop¹², Burkhard F Leeb¹³, Stefania Maggi¹⁴, Ouafa Mkinsi¹⁵, Anton S Povzun¹⁶, Daniel Prieto-Alhambra¹⁷, Thierry Thomas¹⁸, Daniel Uebelhart¹⁹, Nicola Veronese¹⁴, Cyrus Cooper²⁰

Affiliations

¹ Department of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium.
² Arthritis Research UK Centre for Sport, Exercise and Osteoarthritis, University of Oxford, Oxford, UK; MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.
³ Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
⁴ Division of Physical Medicine and Rehabilitation, AP-HP Cochin Hospital, Université Paris Descartes Sorbonne Paris Cité, Paris, France.
⁵ Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Route 52, Porte 53, Domaine du Sart-Tilman, Liège, Belgium.
⁶ Department of Rheumatology, CEDOC, NOVA Medical School, Universidade Nova de Lisboa, CHLO, Hospital Egas Moniz, Lisbon, Portugal.
⁷ Division of Rheumatology, INSERM UMR 1033, Université de Lyon, Hôpital E Herriot, Lyon, France.
⁸ TRB Chemedica International SA, Geneva, Switzerland.
⁹ Biochemistry Department, College of Science, King Saud University, Riyadh, Saudi Arabia.
¹⁰ MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.
¹¹ Department of Rheumatology, Bone and Joint Research Unit, Fundación Jiménez Diaz, Universidad Autonoma, Madrid, Spain.
¹² Scientific Office, Austrian Medicines and Medical Devices Agency, AGES, Vienna, Austria.
¹³ Second Department of Medicine, Centre for Rheumatology Lower Austria, State Hospital Stockerau, Stockerau, Austria.
¹⁴ Aging Program, National Research Council, Padova, Italy.
¹⁵ Rheumatology Department, IBN ROCHD University Hospital, Casablanca, Morocco.
¹⁶ Scientific Research Institute of Emergency Care n.a. l.l. Dzhanelidze, Saint-Petersburg, Russia.
¹⁷ Musculoskeletal Pharmaco and Device Epidemiology, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK; NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, UK.
¹⁸ Department of Rheumatology, Hôpital Nord, CHU de St-Etienne & INSERM 1059, Université de Lyon, Saint-Etienne, France.
¹⁹ Division of Musculoskeletal, Internal Medicine and Oncological Rehabilitation, Department of Orthopaedics and Traumatology, Hôpital du Valais (HVS), Centre Hospitalier du Valais Romand (CHVR), CVP, Crans-Montana, Switzerland.
²⁰ MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK; NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, UK. Electronic address: cc@mrc.soton.ac.uk.

PMID: 29287769
PMCID: PMC5907911
DOI: 10.1016/j.semarthrit.2017.12.003

Review

Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)

Jean-Yves L Reginster et al. Semin Arthritis Rheum. 2018 Aug.

. 2018 Aug;48(1):1-8.

doi: 10.1016/j.semarthrit.2017.12.003. Epub 2017 Dec 7.

Authors

Affiliations

¹ Department of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium.
² Arthritis Research UK Centre for Sport, Exercise and Osteoarthritis, University of Oxford, Oxford, UK; MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.
³ Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
⁴ Division of Physical Medicine and Rehabilitation, AP-HP Cochin Hospital, Université Paris Descartes Sorbonne Paris Cité, Paris, France.
⁵ Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Route 52, Porte 53, Domaine du Sart-Tilman, Liège, Belgium.
⁶ Department of Rheumatology, CEDOC, NOVA Medical School, Universidade Nova de Lisboa, CHLO, Hospital Egas Moniz, Lisbon, Portugal.
⁷ Division of Rheumatology, INSERM UMR 1033, Université de Lyon, Hôpital E Herriot, Lyon, France.
⁸ TRB Chemedica International SA, Geneva, Switzerland.
⁹ Biochemistry Department, College of Science, King Saud University, Riyadh, Saudi Arabia.
¹⁰ MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.
¹¹ Department of Rheumatology, Bone and Joint Research Unit, Fundación Jiménez Diaz, Universidad Autonoma, Madrid, Spain.
¹² Scientific Office, Austrian Medicines and Medical Devices Agency, AGES, Vienna, Austria.
¹³ Second Department of Medicine, Centre for Rheumatology Lower Austria, State Hospital Stockerau, Stockerau, Austria.
¹⁴ Aging Program, National Research Council, Padova, Italy.
¹⁵ Rheumatology Department, IBN ROCHD University Hospital, Casablanca, Morocco.
¹⁶ Scientific Research Institute of Emergency Care n.a. l.l. Dzhanelidze, Saint-Petersburg, Russia.
¹⁷ Musculoskeletal Pharmaco and Device Epidemiology, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK; NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, UK.
¹⁸ Department of Rheumatology, Hôpital Nord, CHU de St-Etienne & INSERM 1059, Université de Lyon, Saint-Etienne, France.
¹⁹ Division of Musculoskeletal, Internal Medicine and Oncological Rehabilitation, Department of Orthopaedics and Traumatology, Hôpital du Valais (HVS), Centre Hospitalier du Valais Romand (CHVR), CVP, Crans-Montana, Switzerland.
²⁰ MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK; NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, UK. Electronic address: cc@mrc.soton.ac.uk.

PMID: 29287769
PMCID: PMC5907911
DOI: 10.1016/j.semarthrit.2017.12.003

Abstract

Objectives: To gather expert opinion on the conduct of clinical trials that will facilitate regulatory review and approval of appropriate efficacious pharmacological treatments for hand osteoarthritis (OA), an area of high unmet clinical need.

Methods: The European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal diseases (ESCEO) organized a working group under the auspices of the International Osteoporosis Foundation (IOF) and the World Health Organization (WHO).

Results: This consensus guideline is intended to provide a reference tool for practice, and should allow for better standardization of the conduct of clinical trials in hand OA. Hand OA is a heterogeneous disease affecting different, and often multiple, joints of the thumb and fingers. It was recognized that the various phenotypes and limitations of diagnostic criteria may make the results of hand OA trials difficult to interpret. Nonetheless, practical recommendations for the conduct of clinical trials of both symptom and structure modifying drugs are outlined in this consensus statement, including guidance on study design, execution, and analysis.

Conclusions: While the working group acknowledges that the methodology for performing clinical trials in hand OA will evolve as knowledge of the disease increases, it is hoped that this guidance will support the development of new pharmacological treatments targeting hand OA.

Keywords: Clinical trials; Guidelines; Hand osteoarthritis; Pharmacological treatment.

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Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)

Affiliations

Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)

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