An Open-label, Observational 12-week Study to Assess Health-related Quality of Life and Patient-reported Outcomes in Patients With Rheumatoid Arthritis Treated With Certolizumab Pegol
An open-label, prospective, and post-authorization observational study. This
non-interventional study is designed to establish the importance of the measurement of HRQoL
data and patient-reported outcomes in clinical practice in patients with RA, and to assess
efficacy and safety use of CZP according to the summary of product characteristics.
Observational Model: Cohort, Time Perspective: Prospective
Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
The HAQ-DI is a measure of function in Rheumatoid Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability.
From Baseline (Week 0) to Week 12
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