DDT COA #000015: PROMIS® Short Form Fatigue 10a in Rheumatoid Arthritis

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)
Sonya Eremenco

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

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Update	8/16/17	FDA Response	3/5/18
Qualification Plan - Accepted Appendix A Appendix B Attachment 1 Attachment 2	3/25/19	FDA Response (Accepted)	9/13/19