Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab

Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab (ROCKA Study)

The study is designed as a prospective, observational study to assess the effect of adalimumab on health-related quality of life (QoL) and work productivity in patients with rheumatoid arthritis (RA) in Korea.

Inclusion Criteria:

• Subject has a diagnosis of RA as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR/the European League against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis).
• Male or female subject ≥ 18 years of age (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label.
• Patients with moderate to severe RA defined as Disease Activity Score in 28 Joints (DAS28) (ESR) or DAS28 (CRP) > 3.2
• Biologically treatment naïve and initiated adalimumab at baseline visit
• Availability of clinical data of the previous 12 weeks prior to baseline
• Ability to self-complete patient questionnaires
• Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion Criteria:

• Patients who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks.
• Participation in any RA-related clinical trial at the time of enrolment, at baseline or at any point during the past 24 weeks prior to baseline
• Patients who in the clinician's view, may not be able to accurately report their QoL or prior resource utilization
• Patients who in the clinician's view, may not be able to adhere to adalimumab therapy over 24 weeks.