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, Nigel K Arden, Ida K Haugen, Francois Rannou, Etienne Cavalier, Olivier Bruyère, Jaime Branco, Roland Chapurlat, Sabine Collaud Basset, Nasser M Al-Daghri, Elaine M Dennison, Gabriel Herrero-Beaumont, Andrea Laslop, Burkhard F Leeb, Stefania Maggi, Ouafa Mkinsi, Anton S Povzun, Daniel Prieto-Alhambra, Thierry Thomas, Daniel Uebelhart & 2 others Nicola Veronese, Cyrus Cooper

Research output: Contribution to journalReview article

4 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1-8
JournalSeminars in Arthritis and Rheumatism
Early online date7 Dec 2017
DOIs
Publication statusPublished - Aug 2018

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Musculoskeletal Diseases
Osteoarthritis
Osteoporosis
Hand
Economics
Clinical Trials
Pharmacology
Guidelines
Finger Joint
Thumb
Expert Testimony
Phenotype

Keywords

  • Hand osteoarthritis
  • Clinical trials
  • Guidelines
  • Pharmacological treatment

Cite this

Reginster, Jean-Yves L ; Arden, Nigel K ; Haugen, Ida K ; Rannou, Francois ; Cavalier, Etienne ; Bruyère, 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 ; Cooper, Cyrus. / 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). In: Seminars in Arthritis and Rheumatism. 2018 ; pp. 1-8.
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title = "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)",
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 = "Hand osteoarthritis, Clinical trials, Guidelines, Pharmacological treatment",
author = "Reginster, {Jean-Yves L} and Arden, {Nigel K} and Haugen, {Ida K} and Francois Rannou and Etienne Cavalier and Olivier Bruy{\`e}re and Jaime Branco and Roland Chapurlat and {Collaud Basset}, Sabine and Al-Daghri, {Nasser M} and Dennison, {Elaine M} and Gabriel Herrero-Beaumont and Andrea Laslop and Leeb, {Burkhard F} and Stefania Maggi and Ouafa Mkinsi and Povzun, {Anton S} and Daniel Prieto-Alhambra and Thierry Thomas and Daniel Uebelhart and Nicola Veronese and Cyrus Cooper",
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Reginster, J-YL, Arden, NK, Haugen, IK, Rannou, F, Cavalier, E, Bruyère, O, Branco, J, Chapurlat, R, Collaud Basset, S, Al-Daghri, NM, Dennison, EM, Herrero-Beaumont, G, Laslop, A, Leeb, BF, Maggi, S, Mkinsi, O, Povzun, AS, Prieto-Alhambra, D, Thomas, T, Uebelhart, D, Veronese, N & Cooper, C 2018, '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, pp. 1-8. https://doi.org/10.1016/j.semarthrit.2017.12.003

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). / Reginster, Jean-Yves L; Arden, Nigel K; Haugen, Ida K; Rannou, Francois; Cavalier, Etienne; Bruyère, 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; Cooper, Cyrus.

In: Seminars in Arthritis and Rheumatism, 08.2018, p. 1-8.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis

T2 - Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)

AU - Reginster, Jean-Yves L

AU - Arden, Nigel K

AU - Haugen, Ida K

AU - Rannou, Francois

AU - Cavalier, Etienne

AU - Bruyère, Olivier

AU - Branco, Jaime

AU - Chapurlat, Roland

AU - Collaud Basset, Sabine

AU - Al-Daghri, Nasser M

AU - Dennison, Elaine M

AU - Herrero-Beaumont, Gabriel

AU - Laslop, Andrea

AU - Leeb, Burkhard F

AU - Maggi, Stefania

AU - Mkinsi, Ouafa

AU - Povzun, Anton S

AU - Prieto-Alhambra, Daniel

AU - Thomas, Thierry

AU - Uebelhart, Daniel

AU - Veronese, Nicola

AU - Cooper, Cyrus

N1 - Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

PY - 2018/8

Y1 - 2018/8

N2 - 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.

AB - 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.

KW - Hand osteoarthritis

KW - Clinical trials

KW - Guidelines

KW - Pharmacological treatment

U2 - 10.1016/j.semarthrit.2017.12.003

DO - 10.1016/j.semarthrit.2017.12.003

M3 - Review article

SP - 1

EP - 8

JO - Seminars in Arthritis and Rheumatism

JF - Seminars in Arthritis and Rheumatism

SN - 0049-0172

ER -