N/A
Completed N=91
Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab
Source: ClinicalTrials.gov NCT02627924 ↗Enrolled (actual)
91
Serious AEs
6.6%
Results posted
Mar 2019
Primary outcomePrimary: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24 — -0.67 units on a scale — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24 |
-0.67 | <0.0001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 |
-0.46 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24 |
65.8; 77.5 | — |
| SECONDARY Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24 |
6.56; 9.51; 5.26; 6.63 | <0.0001 sig |
| SECONDARY Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24 |
0.15; 0.18 | <0.0001 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 |
-19; -25; -15; -25 | 0.0098 sig |
| SECONDARY Patient Treatment Satisfaction |
9; 27; 30; 15; 24; 19 | — |
| SECONDARY Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis |
2; 87; 4; 6; 0; 3 | — |
| SECONDARY Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis |
19; 5; 2; 4; 4; 5 | — |
| SECONDARY Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis |
3 | — |
| SECONDARY Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis |
— | — |
| SECONDARY Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis |
36; 32; 26; 44 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02627924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.