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Center for Global Research Data

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

Lead Investigator: John “Devin” Peipert, Northwestern University
Title of Proposal Research: Justification of PROMIS (FACIT) Fatigue Short Form 10a scale for FDA Drug Development ToolQualification in Rheumatoid Arthritis
Vivli Data Request: 4950
Funding Source: Yes; Contract to Critical Path Institute
Potential Conflicts of Interest: None

Summary of the Proposed Research:

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.

Requested Studies:

Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO)
Sponsor: AbbVie
Study ID: NCT00234897
Sponsor ID: M04-684

STAR Trial
Study ID: DE031
Sponsor ID: DE031

A Multicenter, Randomized, Double-Period, Double − Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)
Sponsor: Abbott
Study ID: NCT00420927
Sponsor ID: M06-810