title: Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA.
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.
authors.affiliation: Hietzing Hospital, Vienna, Austria.
authors.forename: Josef S
authors.initials: JS
authors.lastname: Smolen
authors.forename: Maarten
authors.initials: M
authors.lastname: Boers
authors.forename: Eric C
authors.initials: EC
authors.lastname: Abadie
authors.forename: Ferdinand C
authors.initials: FC
authors.lastname: Breedveld
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.forename: Thomas
authors.initials: T
authors.lastname: Bardin
authors.forename: Niti
authors.initials: N
authors.lastname: Goel
authors.forename: Dominique J
authors.initials: DJ
authors.lastname: Ethgen
authors.forename: Bernard P
authors.initials: BP
authors.lastname: Avouac
authors.forename: Willard H
authors.initials: WH
authors.lastname: Dere
authors.forename: Patrick
authors.initials: P
authors.lastname: Durez
authors.forename: Marco
authors.initials: M
authors.lastname: Matucci-Cerinic
authors.forename: Bruno
authors.initials: B
authors.lastname: Flamion
authors.forename: Andrea
authors.initials: A
authors.lastname: Laslop
authors.forename: Frits J
authors.initials: FJ
authors.lastname: Lekkerkerker
authors.forename: Pierre
authors.initials: P
authors.lastname: Miossec
authors.forename: Bruce H
authors.initials: BH
authors.lastname: Mitlak
authors.forename: Sif
authors.initials: S
authors.lastname: Ormarsdóttir
authors.forename: Laurence
authors.initials: L
authors.lastname: Paolozzi
authors.forename: Ravi
authors.initials: R
authors.lastname: Rao
authors.forename: Susan
authors.initials: S
authors.lastname: Reiter
authors.forename: Yannis
authors.initials: Y
authors.lastname: Tsouderos
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Reginster
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence / Q000639:trends*; D005060:Europe; D006287:Health Planning Guidelines; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage / Q000627:therapeutic use; D010919:Placebos; D012213:Rheumatic Fever / Q000188:drug therapy*; D013997:Time Factors
chemical_list: D018501:Antirheumatic Agents; D010919:Placebos; D008727:Methotrexate