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

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)

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
In transition to 507 process 

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 History

Qualification Submission Date Received FDA Submission Decision & Recommendations Date
Update 8/16/17 FDA Response 3/5/18

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