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Start Over Author "Mitlak, Bruce" Journal current medical research and opinion
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4. Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA

Author

Smolen, Josef S., primary, Boers, Maarten, additional, Abadie, Eric C., additional, Breedveld, Ferdinand C., additional, Emery, Paul, additional, Bardin, Thomas, additional, Goel, Niti, additional, Ethgen, Dominique J., additional, Avouac, Bernard P., additional, Dere, Willard H., additional, Durez, Patrick, additional, Matucci-Cerinic, Marco, additional, Flamion, Bruno, additional, Laslop, Andrea, additional, Lekkerkerker, Frits J., additional, Miossec, Pierre, additional, Mitlak, Bruce H., additional, Ormarsdóttir, Sif, additional, Paolozzi, Laurence, additional, Rao, Ravi, additional, Reiter, Susan, additional, Tsouderos, Yannis, additional, and Reginster, Jean-Yves, additional

Published
2010
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7. Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA.

Author

Smolen JS, Boers M, Abadie EC, Breedveld FC, Emery P, Bardin T, Goel N, Ethgen DJ, Avouac BP, Dere WH, Durez P, Matucci-Cerinic M, Flamion B, Laslop A, Lekkerkerker FJ, Miossec P, Mitlak BH, Ormarsdóttir S, Paolozzi L, Rao R, Reiter S, Tsouderos Y, and Reginster JY

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

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.

Published
2011
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