Despite tremendous advances in the treatment of rheumatoid arthritis over the last several decades, many holes exist in our knowledge base about how best to apply this vast armamentarium to provide optimal treatment for each patient. Pharmaceutical studies have been done primarily for drug approval and registration and have provided highly effective new treatments, but have not addressed many important clinical issues. Concerns about these knowledge gaps led the American College of Rheumatology to organize a meeting of RA clinical trial experts last year. The ACR Committee on Research convened a consensus meeting in July, which resulted in a commentary¹ in Arthritis & Rheumatism summarizing the ACR's position on a variety of trial design issues.

Building on this meeting, additional meetings were held with colleagues at the FDA, and in May 2011, the ACR president convened a task force to examine the FDA's guidance FDA guidance document for clinical trials in rheumatoid arthritis (last updated in 1999). After meeting with the FDA in September, the task force identified three priority areas for expedited revision:

• Ethical use of placebo, including defining acceptable duration and criteria for failure and mandatory trial withdrawal
• Remission: New claims should use the new ACR/EULAR criteria² and remission claims with non-commitant ongoing therapy should be considered
• Biomarkers and Imaging outcomes (MRI and/or ultrasound) as potential early markers of response³

After meeting with additional investigators at the 2011 ACR/ARHP Annual Scientific Meeting in Chicago, the task force has begun work on revising these areas within the guidance document.

Comments were due February 15, 2012. Thank you for your participation. Please stay tuned for further developments.

1: O'Dell JR, Mikuls TR, Colbert RA, Weinblatt ME. Rheumatoid arthritis consensus conference: Clinical trial priorities and trial design issues. Arthritis Rheum. 2011 Aug;63(8):2151-2156.

2: Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum 2011; 63(3):573-586.

3: Strand V, Kingsbury S, Woodworth T, Landewe R, Ostergaard M, Peterfy C, van der Heijde D, D'Agostino MA, Maksymovych W, Tak PP, Wells G, Conaghan P: Sharp Symposium: Important findings in examination of imaging methods and biomarkers for assessment of joint damage in Rheumatoid Arthritis. J Rheumatol 2011: 38:2009–13.