Rheumatoid Arthritis (RA) affects about 1% of the population in Western countries and is characterized by painful inflammation of the joints that leads to physical disability. The objective of the RA Working Group is to generate evidence to support a PRO measure that will support the evaluation of treatment benefit in medical product clinical trials for patients with mild to severe RA, with the intention to support claims in product labeling. Current RA clinical trial endpoints lack inclusion of concepts deemed important to patients with RA, including fatigue. The current focus of the RA Working Group is the qualification of the PROMIS® Fatigue Short Form 10a as an endpoint measure of fatigue severity for RA clinical trials.
Working Group Sponsors
Boehringer Ingelheim Pharmaceuticals, Inc.
Eli Lilly and Company
UCB Pharma Ltd.