Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China (ROCKI Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- AbbVie
- Enrollment
- 55
- Primary Endpoint
- Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this study was to assess the effectiveness of adalimumab on health and disability outcomes in participants with rheumatoid arthritis (RA) in China.
Detailed Description
This was a prospective, multicenter, observational study to assess the effectiveness of adalimumab on health-related quality of life (QoL) and work productivity in participants with rheumatoid arthritis (RA) in routine clinical practice in China. The decision to prescribe adalimumab for RA was based on clinical practice criteria without taking participation in this study into account. Participants were included in the study after a physician's decision of initiating adalimumab treatment. Participants were followed for 24 weeks, with scheduled study visits at baseline, Week 12 and Week 24.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant had a diagnosis of rheumatoid arthritis (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)
- •Participants with moderate to severe RA defined as a Disease Activity Score in 28 Joints (DAS28) Erythrocyte Sedimentation Rate (ESR) or DAS28 C-Reactive Protein (CRP) score \>3.2
- •Biologically treatment naïve and initiated adalimumab at baseline visit, as per standard daily clinical practice
- •Availability of clinical data of the previous 12 weeks prior to baseline
- •Ability to self-complete participant questionnaires.
- •Participants had signed the authorization (or informed consent where applicable) to disclose and use personal health information after having been prescribed adalimumab
Exclusion Criteria
- •Participants who were pregnant or breastfeeding at enrollment or wished to become pregnant in the next 24 weeks.
- •Participation in any RA-related clinical trial at the time of enrollment, at baseline, or at any point during the past 24 weeks prior to baseline
- •Participants, who in the clinician's view, may not have been able to accurately report their quality of life (QoL) or prior resource utilization
- •Participants, who in the clinician's view, may not have been able to adhere to adalimumab therapy over 24 weeks
Outcomes
Primary Outcomes
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24
Time Frame: Baseline and Week 24
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline.
Secondary Outcomes
- Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24(Baseline, Week 12, and Week 24)
- Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12(Baseline and Week 12)
- Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index(Baseline, Week 12, and Week 24)
- Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score(Baseline, Week 12, and Week 24)
- Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score(Baseline, Week 12, and Week 24)
- Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score(Baseline, Week 12, and Week 24)
- Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score(Baseline, Week 12, and Week 24)