Skip to main content

Main menu

  • Home
  • Content
    • First Release
    • Current
    • Archives
    • Collections
    • Audiovisual Rheum
    • COVID-19 and Rheumatology
  • Resources
    • Guide for Authors
    • Submit Manuscript
    • Payment
    • Reviewers
    • Advertisers
    • Classified Ads
    • Reprints and Translations
    • Permissions
    • Meetings
    • FAQ
    • Policies
  • Subscribers
    • Subscription Information
    • Purchase Subscription
    • Your Account
    • Terms and Conditions
  • About Us
    • About Us
    • Editorial Board
    • Letter from the Editor
    • Duncan A. Gordon Award
    • Privacy/GDPR Policy
    • Accessibility
  • Contact Us
  • JRheum Supplements
  • Services

User menu

  • My Cart
  • Log In
  • Log Out

Search

  • Advanced search
The Journal of Rheumatology
  • JRheum Supplements
  • Services
  • My Cart
  • Log In
  • Log Out
The Journal of Rheumatology

Advanced Search

  • Home
  • Content
    • First Release
    • Current
    • Archives
    • Collections
    • Audiovisual Rheum
    • COVID-19 and Rheumatology
  • Resources
    • Guide for Authors
    • Submit Manuscript
    • Payment
    • Reviewers
    • Advertisers
    • Classified Ads
    • Reprints and Translations
    • Permissions
    • Meetings
    • FAQ
    • Policies
  • Subscribers
    • Subscription Information
    • Purchase Subscription
    • Your Account
    • Terms and Conditions
  • About Us
    • About Us
    • Editorial Board
    • Letter from the Editor
    • Duncan A. Gordon Award
    • Privacy/GDPR Policy
    • Accessibility
  • Contact Us
  • Follow jrheum on Twitter
  • Visit jrheum on Facebook
  • Follow jrheum on LinkedIn
  • Follow jrheum on YouTube
  • Follow jrheum on Instagram
  • Follow jrheum on RSS
Abstract

Development of draft validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting structural damage endpoints in rheumatoid arthritis and spondyloarthritis clinical trials.

Walter P Maksymowych, Robert Landewe, Maarten Boers, Patrick Garnero, Piet Geusens, Hani El-Gabalawy, Dick Heinegard, Virginia B Kraus, Virginia Krause, Stefan Lohmander, John Matyas, Tore Saxne and Desiree van der Heijde
The Journal of Rheumatology March 2007, 34 (3) 634-640;
Walter P Maksymowych
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Robert Landewe
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Maarten Boers
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Patrick Garnero
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Piet Geusens
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Hani El-Gabalawy
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Dick Heinegard
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Virginia B Kraus
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Virginia Krause
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Stefan Lohmander
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
John Matyas
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Tore Saxne
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Desiree van der Heijde
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • References
  • Info & Metrics
  • PDF
  • eLetters
PreviousNext
Loading

Abstract

OBJECTIVE: Recent work has shown that several soluble biomarkers, detectable in peripheral blood, synovial fluid, and/or urine, reflect remodeling of joint tissues and may therefore constitute outcome measures that reflect joint damage. Consequently, it is now desirable to begin the process of developing criteria for validation of a soluble biomarker as an outcome measure reflecting structural damage progression in trials of disease-modifying therapies for rheumatoid arthritis (RA) and spondyloarthritis (SpA). Our objective was to develop validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting radiological endpoints in RA and SpA clinical trials. METHODS: A special interest group was established comprising investigators with expertise in soluble biomarker assay development as well as in outcomes research. This project was initiated by means of a Delphi consensus exercise. A list of draft criteria was first generated following a review of a US National Institutes of Health (NIH) 2000 white paper (available at: http://www.niams.nih.gov/ne/oi/ oabiomarwhipap.htm) that focused on biomarkers in OA, and these were organized under subject headings relevant to the OMERACT filter: truth, discrimination, and feasibility. Additional criteria were solicited from the working group. This was followed by 3 rounds of voting. RESULTS: A list of 31 criteria was generated prior to voting. The first 2 rounds of voting resulted in cumulative agreement that 19 criteria be retained and 4 discarded, while discrepancies were recorded for 8 criteria. In the third round of voting, cumulative agreement was achieved to retain 5 of the 8 discrepant criteria, so that the final list included 24 criteria. CONCLUSION: A draft set of criteria for validation of a soluble biomarker to be regarded as reflecting radiological damage endpoints in clinical trials has been proposed on the basis of consensus.

PreviousNext
Back to top

In this issue

The Journal of Rheumatology
Vol. 34, Issue 3
1 Mar 2007
  • Table of Contents
  • Table of Contents (PDF)
  • Index by Author
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word about The Journal of Rheumatology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Development of draft validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting structural damage endpoints in rheumatoid arthritis and spondyloarthritis clinical trials.
(Your Name) has forwarded a page to you from The Journal of Rheumatology
(Your Name) thought you would like to see this page from the The Journal of Rheumatology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Development of draft validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting structural damage endpoints in rheumatoid arthritis and spondyloarthritis clinical trials.
Walter P Maksymowych, Robert Landewe, Maarten Boers, Patrick Garnero, Piet Geusens, Hani El-Gabalawy, Dick Heinegard, Virginia B Kraus, Virginia Krause, Stefan Lohmander, John Matyas, Tore Saxne, Desiree van der Heijde
The Journal of Rheumatology Mar 2007, 34 (3) 634-640;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

 Request Permissions

Share
Development of draft validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting structural damage endpoints in rheumatoid arthritis and spondyloarthritis clinical trials.
Walter P Maksymowych, Robert Landewe, Maarten Boers, Patrick Garnero, Piet Geusens, Hani El-Gabalawy, Dick Heinegard, Virginia B Kraus, Virginia Krause, Stefan Lohmander, John Matyas, Tore Saxne, Desiree van der Heijde
The Journal of Rheumatology Mar 2007, 34 (3) 634-640;
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One
Bookmark this article

Jump to section

  • Article
  • References
  • Info & Metrics
  • PDF
  • eLetters

Related Articles

Cited By...

Similar Articles

Content

  • First Release
  • Current
  • Archives
  • Collections
  • Audiovisual Rheum
  • COVID-19 and Rheumatology

Resources

  • Guide for Authors
  • Submit Manuscript
  • Author Payment
  • Reviewers
  • Advertisers
  • Classified Ads
  • Reprints and Translations
  • Permissions
  • Meetings
  • FAQ
  • Policies

Subscribers

  • Subscription Information
  • Purchase Subscription
  • Your Account
  • Terms and Conditions

More

  • About Us
  • Contact Us
  • My Alerts
  • My Folders
  • Privacy/GDPR Policy
  • RSS Feeds
The Journal of Rheumatology
The content of this site is intended for health care professionals.
Copyright © 2022 by The Journal of Rheumatology Publishing Co. Ltd.
Print ISSN: 0315-162X; Online ISSN: 1499-2752
Powered by HighWire