N/A
Completed N=55
Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China
Source: ClinicalTrials.gov NCT02668640 ↗Enrolled (actual)
55
Serious AEs
3.6%
Results posted
Sep 2019
Primary outcomePrimary: Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24 — -0.3 units on a scale — p==0.0002
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24 |
-0.3 | =0.0002 sig |
| SECONDARY Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12 |
-0.2 | =0.0006 sig |
| SECONDARY 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 |
6.50; 0.44; 4.90; 6.01 | <0.0001 sig |
| SECONDARY Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index |
0.11; 0.19 | <0.0001 sig |
| SECONDARY Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score |
-58.4; -20.0 | =0.0137 sig |
| SECONDARY Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score |
-10.0; -20.0 | =0.0026 sig |
| SECONDARY Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score |
23; 20 | — |
| SECONDARY Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score |
50.0; 51.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT02668640). 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.