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.

Key words::

• Biologics
• Marketing authorisation
• Rheumatoid arthritis
• Treatment

Transparency

Declaration of funding

The paper was integrally funded by Group for the Respect of Ethics and Excellence in Science (GREES).

Declaration of financial/other relationships

J.S. has disclosed that he has received grant support and/or honoraria from Abbott, Amgen, BMS, Centocor, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB and Wyeth. M.B. has disclosed that he has received honoraria or grant support from Roche, Novartis, GSK, Schering-Plough, BMS, Combinatorx, Augurex, Nitec, UCB, Genentech and Mundipharma. P.D. has disclosed that he has received honoraria from Abbott, Centocor, Wyeth, Roche, BMS and Schering Plough. P.E. has disclosed that he has received grant support and/or honoraria from Abbott, BMS, Centocor, Pfizer, Roche, Schering-Plough, UCB, Sanofi-Aventis and Wyeth. W.D. has disclosed that he is an employee of Amgen. D.E. has disclosed that he is an employee of Medimmune. L.P. has disclosed that he is an employee of Sanofi-Aventis. R.R. has disclosed that he is a Roche employee. B.M. has disclosed that he is an Eli Lilly employee. Y.T. has disclosed that he is employed by Servier. E.A., B.F., S.R. and S.O. have no conflict of interest.

Acknowledgement

The authors have disclosed that they had no outside editorial assistance in preparing this manuscript.