Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in Taiwan (ROCKI)

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02616380

P15-778

Details and patient eligibility

About

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 Taiwan.

Enrollment: 100 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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 subjects >= 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) Erythrocyte Sedimentation Rate (ESR) or DAS28 C- Reactive Protein (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.

Trial design

100 participants in 1 patient group

Adalimumab

Description:

Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.