Document Detail

Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA.
MedLine Citation:
PMID:  21142618     Owner:  NLM     Status:  MEDLINE    
Since 2003, the European Medicines Agency (EMA) document, 'Points to consider on clinical investigation of medicinal products other than NSAIDs (nonsteroidal anti-inflammatory drugs) for the treatment of rheumatoid arthritis' has provided guidance for the clinical development of both biologic and non-biologic disease-modifying antirheumatic drugs (DMARDs). In the last few years, several new products have been developed or are in development for the treatment of RA, which offer significant efficacy with regard to disease control, including prevention of structural damage and disability. Concurrently, novel insights have been gained with respect to the assessment of disease activity, joint damage and disability. New treatment strategies have been established which relate to early therapy, tight control and rapid switching of medication. Accordingly, several new EULAR/ACR recommendations have been or are being developed. Several important additions and changes are needed in the 2003 guidance to incorporate the current scientific knowledge into clinical trial design for the development of future products. Under the auspices of the Group for the Respect of Ethics and Excellence in Science (GREES), a group of experts in the field of RA and clinical trial design met to provide a consensus recommendation for an update to the 2003 EMA guidance document.
Josef S Smolen; Maarten Boers; Eric C Abadie; Ferdinand C Breedveld; Paul Emery; Thomas Bardin; Niti Goel; Dominique J Ethgen; Bernard P Avouac; Willard H Dere; Patrick Durez; Marco Matucci-Cerinic; Bruno Flamion; Andrea Laslop; Frits J Lekkerkerker; Pierre Miossec; Bruce H Mitlak; Sif Ormarsdóttir; Laurence Paolozzi; Ravi Rao; Susan Reiter; Yannis Tsouderos; Jean-Yves Reginster;
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Publication Detail:
Type:  Journal Article; Practice Guideline; Research Support, Non-U.S. Gov't     Date:  2010-12-09
Journal Detail:
Title:  Current medical research and opinion     Volume:  27     ISSN:  1473-4877     ISO Abbreviation:  Curr Med Res Opin     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-01-13     Completed Date:  2011-05-12     Revised Date:  2014-06-03    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  England    
Other Details:
Languages:  eng     Pagination:  315-25     Citation Subset:  IM    
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MeSH Terms
Antirheumatic Agents / therapeutic use*
Clinical Trials, Phase III as Topic
Drug Approval / legislation & jurisprudence*
Drug and Narcotic Control / legislation & jurisprudence,  trends*
Health Planning Guidelines*
Methotrexate / administration & dosage,  therapeutic use
Practice Guidelines as Topic
Rheumatic Fever / drug therapy*
Time Factors
Grant Support
18475//Arthritis Research UK
Reg. No./Substance:
0/Antirheumatic Agents; 0/Placebos; YL5FZ2Y5U1/Methotrexate

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

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