Document Detail

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.
MedLine Citation:
PMID:  17343311     Owner:  NLM     Status:  MEDLINE    
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: 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.
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
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Journal of rheumatology     Volume:  34     ISSN:  0315-162X     ISO Abbreviation:  J. Rheumatol.     Publication Date:  2007 Mar 
Date Detail:
Created Date:  2007-03-08     Completed Date:  2007-04-10     Revised Date:  2008-01-09    
Medline Journal Info:
Nlm Unique ID:  7501984     Medline TA:  J Rheumatol     Country:  Canada    
Other Details:
Languages:  eng     Pagination:  634-40     Citation Subset:  IM    
Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Arthritis, Rheumatoid / blood,  pathology*
Biological Markers*
Delphi Technique
Outcome Assessment (Health Care) / standards*
Predictive Value of Tests
Reproducibility of Results
Spondylarthritis / blood,  pathology*
Treatment Outcome
Reg. No./Substance:
0/Biological Markers
Erratum In:
J Rheumatol. 2007 Dec;34(12):2506
Note: Krause, Virginia [corrected to Kraus, Virginia B]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Testing of the preliminary OMERACT validation criteria for a biomarker to be regarded as reflecting ...
Next Document:  Assessing single joints in arthritis clinical trials.