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Boers M. Ann Rheum Dis 2010;69:186–92.

The authors of this review of published trials of currently available biological agents in rheumatoid arthritis found that 3 months of placebo-controlled therapy is adequate to demonstrate clinical efficacy of the agent under evaluation.

 

Registration trials in rheumatoid arthritis (RA), designed to gain regulatory approval for new agents, are generally designed as randomized trials in which placebo or the investigational drug is added to the background disease-modifying antirheumatic drugs (DMARDs) to which patients have had an inadequate response. Regulatory agencies have required that these trials include ≥6 months of randomized therapy, which means that patients in the placebo arm may be continuing therapy already determined to be inadequate for a prolonged period of time.

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