Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA

Curr Med Res Opin. 2011 Feb;27(2):315-25. doi: 10.1185/03007995.2010.542135. Epub 2010 Dec 9.


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.

Publication types

  • Practice Guideline
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antirheumatic Agents / therapeutic use*
  • Clinical Trials, Phase III as Topic
  • Drug Approval / legislation & jurisprudence*
  • Drug and Narcotic Control / legislation & jurisprudence
  • Drug and Narcotic Control / trends*
  • Europe
  • Health Planning Guidelines*
  • Humans
  • Methotrexate / administration & dosage
  • Methotrexate / therapeutic use
  • Placebos
  • Practice Guidelines as Topic
  • Rheumatic Fever / drug therapy*
  • Time Factors


  • Antirheumatic Agents
  • Placebos
  • Methotrexate