The University of Southampton
University of Southampton Institutional Repository

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
db56b103-184d-46e1-9600-f47f7a09a492
Arden, Nigel K.
23af958d-835c-4d79-be54-4bbe4c68077f
Haugen, Ida K.
b65326b9-ae13-468b-929f-c2e307c8e8f6
Rannou, Francois
ddca60fd-e7fe-4f90-89d4-dae0639dcec4
Cavalier, Etienne
f18d781a-5a9d-466c-8e80-c611adce0f97
Bruyere, Olivier
7d127754-d7d6-4328-8f76-212df27727b6
Branco, Jaime
f1c58fe8-c26b-4d12-8205-253b0fcd3ff4
Chapurlat, Roland
9435221c-55dc-4b28-a6ee-4b2a05b35674
Collaud Basset, Sabine
ca710e3a-1b6b-42df-b0b5-fd12c4146d85
Al-Daghri, Nasser M.
a8c55fec-b69e-47eb-9d48-5a259eaac01c
Dennison, Elaine M.
ee647287-edb4-4392-8361-e59fd505b1d1
Herrero-Beaumont, Gabriel
514e463a-d5b5-400d-aa6b-1b0ac2f720dc
Laslop, Andrea
ca0887e1-5fce-4ac3-bbaf-f2aa98be3e0f
Leeb, Burkhard F.
681c729c-41b2-417c-b35a-4e6cf1d8f5f1
Maggi, Stefania
57e7e62a-b7dd-4291-82e3-efc8c9a7e12a
Mkinsi, Ouafa
b3580f74-cc01-4715-ae4f-09b381f8df04
Povzun, Anton S.
8957150b-b43d-47f0-958c-2928a5ada360
Prieto-Alhambra, Daniel
e596722a-2f01-4201-bd9d-be3e180e76a9
Thomas, Thierry
a730aea1-d9bc-4561-bd76-bf43ce200861
Uebelhart, Daniel
cb224382-2034-431a-af69-f32b1ba1d004
Veronese, Nicola
4abdab1f-9d90-4e04-b6ba-4bb6b71b5381
Cooper, Cyrus
e05f5612-b493-4273-9b71-9e0ce32bdad6
Reginster, Jean-Yves
db56b103-184d-46e1-9600-f47f7a09a492
Arden, Nigel K.
23af958d-835c-4d79-be54-4bbe4c68077f
Haugen, Ida K.
b65326b9-ae13-468b-929f-c2e307c8e8f6
Rannou, Francois
ddca60fd-e7fe-4f90-89d4-dae0639dcec4
Cavalier, Etienne
f18d781a-5a9d-466c-8e80-c611adce0f97
Bruyere, Olivier
7d127754-d7d6-4328-8f76-212df27727b6
Branco, Jaime
f1c58fe8-c26b-4d12-8205-253b0fcd3ff4
Chapurlat, Roland
9435221c-55dc-4b28-a6ee-4b2a05b35674
Collaud Basset, Sabine
ca710e3a-1b6b-42df-b0b5-fd12c4146d85
Al-Daghri, Nasser M.
a8c55fec-b69e-47eb-9d48-5a259eaac01c
Dennison, Elaine M.
ee647287-edb4-4392-8361-e59fd505b1d1
Herrero-Beaumont, Gabriel
514e463a-d5b5-400d-aa6b-1b0ac2f720dc
Laslop, Andrea
ca0887e1-5fce-4ac3-bbaf-f2aa98be3e0f
Leeb, Burkhard F.
681c729c-41b2-417c-b35a-4e6cf1d8f5f1
Maggi, Stefania
57e7e62a-b7dd-4291-82e3-efc8c9a7e12a
Mkinsi, Ouafa
b3580f74-cc01-4715-ae4f-09b381f8df04
Povzun, Anton S.
8957150b-b43d-47f0-958c-2928a5ada360
Prieto-Alhambra, Daniel
e596722a-2f01-4201-bd9d-be3e180e76a9
Thomas, Thierry
a730aea1-d9bc-4561-bd76-bf43ce200861
Uebelhart, Daniel
cb224382-2034-431a-af69-f32b1ba1d004
Veronese, Nicola
4abdab1f-9d90-4e04-b6ba-4bb6b71b5381
Cooper, Cyrus
e05f5612-b493-4273-9b71-9e0ce32bdad6

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.

Text
ESCEO consensus guidelines for Hand OA REVISED 08Nov17_clean - Accepted Manuscript
Download (142kB)
Text
1-s2.0-S0049017217304626-main - Version of Record
Download (284kB)

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: 18 Mar 2024 05:05

Export record

Altmetrics

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

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×