Justification of PROMIS (FACIT) Fatigue Short Form 10a scale for FDA Drug Development Tool Qualification in Rheumatoid Arthritis

We propose a series of quantitative analyses using data from multiple clinical trials in support of the Center for Drug Evaluation and Research Clinical Outcome Assessment submission of PROMIS Fatigue in Rheumatoid Arthritis Drug Development Tool (DDT) qualification submission. The FDA’s DDT qualification of the PROMIS Fatigue in Rheumatoid Arthritis would enable drug developers to issue labelling claims based on the patient reported outcome of fatigue and allow use of patient-reported fatigue as an endpoint measure in RA treatment trials. Using these data, we will examine and compare the psychometric characteristics, including score distributions and correlations, internal consistency and test-retest reliability, convergent and known groups validity, responsiveness to change, and responder definition of the PROMIS Fatigue (aka FACIT-Fatigue) 10-item version, which was administered at multiple time points in the studies.