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Pivotal clinical trials of several drugs licensed in Europe have used the ‘Points to consider on clinical investigation of medicinal products other than NSAIDs for the treatment of rheumatoid arthritis’, published in 2003 by the European Medicines Agency’s (EMA) Committee for Proprietary Medicinal Products for Human Use (CPMP) [1]. This document was produced to specify requirements for investigation and approval of new DMARDs; however, since it was published we have seen the development of novel therapies for RA (especially biologic agents) and new therapeutic strategies emphasizing early intervention and tight control to achieve low disease activity or remission [2]. In light of this, the ethics and study design of clinical trials need to be reassessed. To address this situation, the authors—a consensus committee bringing together expertise in RA, clinical trial design and regulatory affairs—reviewed the current literature. A consensus was reached, endorsed by all authors, that updates the CHMP guidance, specifically as it relates to, the choice of comparator in different patient populations, the assessment of signs and symptoms and physical function and structural damage evaluation and duration of trials.

Updating the 2003 European regulatory requirements for registering disease-modifying drugs to be used in the treatment of rheumatoid arthritis