EMA finalises guideline on the clinical evaluation of medicinal products in the treatment of rheumatoid arthritis

The European Medicines Agency (EMA) has adopted a guideline on the clinical evaluation of medicinal products in the treatment of rheumatoid arthritis (RA), which is set to officially take effect from 1st July 2018.

The guideline, which was first drafted in 2011, features sections on the criteria and standards for patient selection, possible indications or treatment goals, how to assess efficacy, the strategy and design of clinical trials, clinical safety evaluations and studies in special populations including the elderly and children.

The guideline states that “currently several biomarkers which may predict disease progression and response are under development. In the future, this may lead to a more individually targeted treatment approach.” There are still a considerable number of patients who are resistant to or do not tolerate available pharmacological treatment options therefore new treatment options are in demand. The EMA notes that the optimum treatment goal is remission, or at least low disease activity in patients that do not respond to earlier treatments.

This document is a revision of the Points to Consider adopted in November 2003. Since 2003, the guideline states that new classification criteria for RA have been developed and validated by the American College of Rheumatology’s European League against Rheumatism that allows for earlier DMARD use.

In this guideline a distinction is currently made between trials in DMARD-naïve RA patients or in patients who have had an inadequate response to prior therapy with disease-modifying anti-rheumatic drugs (DMARDs). Recommendations are also introduced on how to measure the prevention of structural bone damage.

To view the guideline on clinical investigation of medicinal products for the treatment of RA, please click here.