Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Rheumatology and Transplant Medicine (DRTM)

DDT COA Number
DDT COA #000015

Instrument Name
PROMIS® Short Form Fatigue 10a in Rheumatoid Arthritis

Disease/Condition
Rheumatoid Arthritis (RA)

Concept of Interest
Fatigue

Context of Use
Adult patients (>18 years) with a definite diagnosis of RA based on a score of ≥ 6 on the American College of Rheumatology/European League Against Rheumatism 2010 Rheumatoid Arthritis Classification Criteria

COA Type
PRO

Qualification Stage
Qualification Plan – Accepted 

Requestor(s)
Critical Path Institute: Patient-Reported Outcome (PRO) Consortium
Rheumatoid Arthritis Working Group

Contact(s)
Stephen Coons

Date Accepted into CDER’s COA Qualification Program
October 14, 2016

Submission and Regulatory Correspondence History