Recommendations for the registration of drugs used in the treatment of rheumatoid arthritis

Rheumatoid arthritis (RA) is the commonest form of chronic inflammatory joint disease and a major target for symptom-modifying and disease-modifying drug therapy. New approaches to the treatment of RA using biological agents targeted to cellular receptors, cytokines and other mediators of inflammation, together with the availability of new methods of outcome assessment, make it timely to reconsider the classification of anti-rheumatic drugs and the requirements for the registration of new drug entities. Under the auspices of GREES (Group for the Respect of Ethics and Excellence in Science), a European Working Group of clinicians with experience in rheumatology, scientists and representatives from industry and national drug licensing authorities have formulated recommendations for the requirements for registration of anti-rheumatic drugs designed for symptom modification, structural modification and the suppression of inflammation, with particular emphasis placed on quality of life assessment by generic and disease-specific validated methods. This paper outlines the group's advice for pre clinical testing, and Phase I, Phase II and Phase III trials to allow licences to be granted for each indication, while recognizing that a single drug may have reason to be approved under several headings.