Rheumatoid arthritis three-month trials are adequate for signs and symptoms claim -- Pfizer.
Executive Summary
RHEUMATOID ARTHRITIS DRUG THREE-MONTH TRIAL DURATION "REMAINS APPROPRIATE for evaluation of agents with a rapid onset of action," Pfizer maintains in Feb. 14 comments on FDA's draft guidance for industry development of RA drugs. "For agents with slower onset or potential for rapid loss of effect," Pfizer suggested, "a minimum of six months may be more appropriate" to gain a claim of reduction in signs and symptoms.