Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards

Dinesh Khanna, Daniel E. Furst, Yannick Allanore, Sangmee Bae, Vijay Bodukam, Philip J. Clements, Maurizio Cutolo, L. Czirják, Christopher P. Denton, Oliver Distler, Ulrich A. Walker, Marco Matucci-Cerinic, Ulf Müller-Ladner, James R. Seibold, Manjit Singh, Alan Tyndall

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objective. SSc is clinically and aetiopathogenically heterogeneous. Consensus standards for more uniform trial design and selection of outcome measures are needed. The objective of this study was to develop evidence-based points to consider (PTCs) for future clinical trials in SSc.Methods. Thirteen international SSc experts experienced in SSc clinical trial design were invited to participate. One researcher with experience in systematic literature review and three trainees were also included. A systematic review using PubMed and the Cochrane Central Register of Controlled Trials was conducted and PTCs when designing clinical trials in SSc were developed. As part of that development we conducted an Internet-based Delphi exercise regarding the main points to be made in the consensus statement. Consensus was defined as achieving a median score of ≥7 of 9.Results. By consensus, the experts decided to develop PTCs for each individual organ system. The current document provides a unifying outline on PTCs regarding general trial design, inclusion/exclusion criteria and analysis. Consensus was achieved regarding all the main points of the PTCs.Conclusion. Using European League Against Rheumatism suggestions for PTCs, a general outline for PTCs for controlled clinical trials in SSc was developed. Specific outlines for individual organ systems are to be published separately. This general outline should lead to more uniform and higher-quality trials and clearly delineate areas where further research is needed.

Original languageEnglish
Article numberkeu288
Pages (from-to)144-151
Number of pages8
JournalRheumatology
Volume54
Issue number1
DOIs
Publication statusPublished - Nov 24 2014

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Keywords

  • Clinical trials
  • Points to consider
  • Systemic sclerosis

ASJC Scopus subject areas

  • Rheumatology
  • Pharmacology (medical)

Cite this

Khanna, D., Furst, D. E., Allanore, Y., Bae, S., Bodukam, V., Clements, P. J., ... Tyndall, A. (2014). Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards. Rheumatology, 54(1), 144-151. [keu288]. https://doi.org/10.1093/rheumatology/keu288

Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards. / Khanna, Dinesh; Furst, Daniel E.; Allanore, Yannick; Bae, Sangmee; Bodukam, Vijay; Clements, Philip J.; Cutolo, Maurizio; Czirják, L.; Denton, Christopher P.; Distler, Oliver; Walker, Ulrich A.; Matucci-Cerinic, Marco; Müller-Ladner, Ulf; Seibold, James R.; Singh, Manjit; Tyndall, Alan.

In: Rheumatology, Vol. 54, No. 1, keu288, 24.11.2014, p. 144-151.

Research output: Contribution to journalArticle

Khanna, D, Furst, DE, Allanore, Y, Bae, S, Bodukam, V, Clements, PJ, Cutolo, M, Czirják, L, Denton, CP, Distler, O, Walker, UA, Matucci-Cerinic, M, Müller-Ladner, U, Seibold, JR, Singh, M & Tyndall, A 2014, 'Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards', Rheumatology, vol. 54, no. 1, keu288, pp. 144-151. https://doi.org/10.1093/rheumatology/keu288
Khanna D, Furst DE, Allanore Y, Bae S, Bodukam V, Clements PJ et al. Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards. Rheumatology. 2014 Nov 24;54(1):144-151. keu288. https://doi.org/10.1093/rheumatology/keu288
Khanna, Dinesh ; Furst, Daniel E. ; Allanore, Yannick ; Bae, Sangmee ; Bodukam, Vijay ; Clements, Philip J. ; Cutolo, Maurizio ; Czirják, L. ; Denton, Christopher P. ; Distler, Oliver ; Walker, Ulrich A. ; Matucci-Cerinic, Marco ; Müller-Ladner, Ulf ; Seibold, James R. ; Singh, Manjit ; Tyndall, Alan. / Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards. In: Rheumatology. 2014 ; Vol. 54, No. 1. pp. 144-151.
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