Clinical trials of new drugs for the treatment of rheumatoid arthritis: focus on early disease

The European Society for Clinical and Economic Aspects
of Osteoporosis, Osteoarthritis and Musculoskeletal
Diseases convened a task force of experts in rheumatoid
arthritis (RA) and clinical trial methodology to comment
on the new draft ‘Guideline on clinical investigation of
medicinal products for the treatment of RA’ released by
the European Medicines Agency (EMA). Special
emphasis was placed by the group on the development
of new drugs for the treatment of early RA. In the
absence of a clear definition of early RA, it was
suggested that clinical investigations in this condition
were conducted in disease-modifying antirheumatic
drugs naïve patients with no more than 1 year disease
duration. The expert group recommended using an
appropriate improvement in disease activity (American
College of Rheumatology (ACR) or Simplified/Clinical
Disease Activity Index (SDAI/CDAI) response criteria) or
low disease activity (by any score) as primary endpoints,
with ACR/European League Against Rheumatism
remission as a secondary endpoint. Finally, as compelling
evidence showed that the Disease Acrivity Score using
28-joint counts (DAS28) might not provide a reliable
definition of remission, or sometimes even low disease
activity, the group suggested replacing DAS28 as a
measurement instrument to evaluate disease activity in
RA clinical trials. Proposed alternatives included SDAI,
CDAI and Boolean criteria.