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

The authors discuss regulatory requirements for the investigation and approval of disease-modifying anti-rheumatic drugs (DMARDs) in Europe. According to the authors, both the choice of comparator and the assessment of joint damage are influenced by the patient population studied. They cite potential indications for the use of a new agent. They point out a need for the new agent to exhibit superior efficacy to placebo in signs and symptoms for established rheumatoid arthritis cases.