N/A
Completed N=100
Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in Taiwan
Source: ClinicalTrials.gov NCT02616380 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Mar 2019
Primary outcomePrimary: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 — -0.44 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 Taiwan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 |
-0.44 | <0.0001 sig |
| SECONDARY Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24 |
5.72; 8.09; 3.67; 5.85 | <0.0001 sig |
| SECONDARY Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24 |
0.23; 0.33 | <0.0001 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 |
-18; -19; -14; -24 | <0.0001 sig |
| SECONDARY Change From Baseline in HAQ DI Score at Week 12 |
-0.34 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24 |
60.4; 59.6 | — |
| SECONDARY Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis |
99; 97; 7; 5; 5; 3 | — |
| SECONDARY Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis |
95; 87; 27; 11; 11; 9 | — |
| SECONDARY Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis |
1 | — |
| SECONDARY Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis |
100; 96; 73; 59 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT02616380). 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.