N/A
Completed N=500
Greek Study on Work Productivity and Sleep in Patients With Rheumatic Diseases Treated With Adalimumab
Source: ClinicalTrials.gov NCT01282372 ↗Enrolled (actual)
500
Serious AEs
6.6%
Results posted
Aug 2015
Primary outcomePrimary: Mean Change From Baseline in Work Time Missed Due to Health Problem — 21.0; -18.9 Impairment percentage
Summary
Treatment with tumor necrosis factor (TNF) inhibitors, especially adalimumab, demonstrated an improvement in work productivity in participants with rheumatic diseases: rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Limited data was available for the effect of adalimumab treatment on sleep in all three diseases (RA, PsA, and AS) and no data was available for the effect of adalimumab treatment on work productivity in PsA. This long term Health-Related Quality of Life (HRQL) observational study was conducted to evaluate the effect of treatment with adalimumab on work productivity and sleep disturbance in Greek participants with moderate to severe rheumatic diseases (RA, PsA, and AS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Work Time Missed Due to Health Problem |
21.0; -18.9 | — |
| PRIMARY Mean Change From Baseline in Impairment While Working Due to Health Problem |
52.8; -40.0 | — |
| PRIMARY Mean Change From Baseline in Overall Work Impairment Due to Health Problem |
57.8; -46.8 | — |
| PRIMARY Mean Change From Baseline in Overall Activity Impairment Due to Health Problem |
62.1; -47.0 | — |
| SECONDARY Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups |
20.7; 24.8; 17.8; -25.5; -21.6; -13.5 | — |
| SECONDARY Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups |
57.0; 49.3; 53.3; -50.5; -33.5; -40.0 | — |
| SECONDARY Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups |
62.3; 53.9; 58.3; -55.2; -40.6; -47.1 | — |
| SECONDARY Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups |
64.5; 59.4; 62.1; -47.5; -45.8; -47.6 | — |
| SECONDARY Mean Disease Activity Score 28 (DAS28) |
5.95; 4.05; 3.39; 3.08; 2.90; 2.72 | — |
| SECONDARY Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
1.60; 0.98; 0.77; 0.65; 0.58; 0.51 | — |
| SECONDARY Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score |
5.75; 3.34; 2.51; 2.05; 1.69; 1.50 | — |
| SECONDARY Mean Psoriatic Arthritis Response Criteria (PsARC) Score |
— | — |
| SECONDARY Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero |
98.8; 72.4; 48.4; 34.0; 32.6; 28.1 | — |
| SECONDARY Mean Erythrocyte Sedimentation Rate (ESR) |
40.2; 25.3; 21.7; 18.5; 17.6; 16.2 | — |
| SECONDARY Mean Plasma Concentrations of C-Reactive Protein (CRP) |
9.94; 5.05; 3.26; 1.94; 1.99; 1.91 | — |
| SECONDARY Mean Visual Analogue Scale (VAS) Score |
65.80; 32.00; 21.90; 15.10; 14.10; 12.00 | — |
| SECONDARY Mean Sleep Disturbance Subscale Score |
50.9; 30.3; 23.4; 19.7; 18.3; 16.6 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with moderate or severe active rheumatic disease, who received adalimumab under normal clinical practice in accordance with the approved local SmPC.
- Participants who provided their consent for data collection and use by AbbVie.
Exclusion Criteria
- Contraindications according to the SmPC.
- Participants who did not participate in other observational studies conducted by Abbvie.
Data sourced from ClinicalTrials.gov (NCT01282372). 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.