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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)

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)
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)
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.
0049-0172
Reginster, Jean-Yves
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Arden, Nigel K.
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Haugen, Ida K.
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Rannou, Francois
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Cavalier, Etienne
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Bruyere, Olivier
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Branco, Jaime
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Chapurlat, Roland
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Collaud Basset, Sabine
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Al-Daghri, Nasser M.
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Dennison, Elaine M.
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Herrero-Beaumont, Gabriel
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Laslop, Andrea
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Leeb, Burkhard F.
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Maggi, Stefania
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Mkinsi, Ouafa
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Povzun, Anton S.
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Prieto-Alhambra, Daniel
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Thomas, Thierry
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Uebelhart, Daniel
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Veronese, Nicola
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Cooper, Cyrus
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Reginster, Jean-Yves
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Arden, Nigel K.
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Haugen, Ida K.
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Rannou, Francois
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Cavalier, Etienne
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Bruyere, Olivier
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Branco, Jaime
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Chapurlat, Roland
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Collaud Basset, Sabine
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Al-Daghri, Nasser M.
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Dennison, Elaine M.
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Herrero-Beaumont, Gabriel
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Laslop, Andrea
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Leeb, Burkhard F.
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Maggi, Stefania
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Mkinsi, Ouafa
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Povzun, Anton S.
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Prieto-Alhambra, Daniel
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Thomas, Thierry
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Uebelhart, Daniel
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Veronese, Nicola
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Cooper, Cyrus
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Reginster, Jean-Yves, Arden, Nigel K., Haugen, Ida K., Rannou, Francois, Cavalier, Etienne, Bruyere, Olivier, Branco, Jaime, Chapurlat, Roland, Collaud Basset, Sabine, Al-Daghri, Nasser M., Dennison, Elaine M., Herrero-Beaumont, Gabriel, Laslop, Andrea, Leeb, Burkhard F., Maggi, Stefania, Mkinsi, Ouafa, Povzun, Anton S., Prieto-Alhambra, Daniel, Thomas, Thierry, Uebelhart, Daniel, Veronese, Nicola and Cooper, Cyrus (2017) 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). Seminars in Arthritis and Rheumatism. (doi:10.1016/j.semarthrit.2017.12.003).

Record type: Article

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.

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ESCEO consensus guidelines for Hand OA REVISED 08Nov17_clean - Accepted Manuscript
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More information

Accepted/In Press date: 1 December 2017
e-pub ahead of print date: 7 December 2017

Identifiers

Local EPrints ID: 416931
URI: http://eprints.soton.ac.uk/id/eprint/416931
ISSN: 0049-0172
PURE UUID: 229f5cf2-f0ae-4b53-b342-7390286ede89
ORCID for Elaine M. Dennison: ORCID iD orcid.org/0000-0002-3048-4961
ORCID for Cyrus Cooper: ORCID iD orcid.org/0000-0003-3510-0709

Catalogue record

Date deposited: 15 Jan 2018 17:30
Last modified: 26 Nov 2021 05:27

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Contributors

Author: Jean-Yves Reginster
Author: Nigel K. Arden
Author: Ida K. Haugen
Author: Francois Rannou
Author: Etienne Cavalier
Author: Olivier Bruyere
Author: Jaime Branco
Author: Roland Chapurlat
Author: Sabine Collaud Basset
Author: Nasser M. Al-Daghri
Author: Gabriel Herrero-Beaumont
Author: Andrea Laslop
Author: Burkhard F. Leeb
Author: Stefania Maggi
Author: Ouafa Mkinsi
Author: Anton S. Povzun
Author: Daniel Prieto-Alhambra
Author: Thierry Thomas
Author: Daniel Uebelhart
Author: Nicola Veronese
Author: Cyrus Cooper ORCID iD

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