N/A
Completed N=183
Study in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium
Source: ClinicalTrials.gov NCT01845818 ↗Enrolled (actual)
183
Serious AEs
0.6%
Results posted
Jan 2019
Primary outcomePrimary: Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined) — -29.15 percentage of TWPI
Summary
This observational study will document to what extent in daily clinical practice the work productivity is affected before and after the start of adalimumab treatment.
Changes in the employment status and work productivity of participants with AS and PsA before and after the start of adalimumab will be noted. The relationship between employment status, work productivity, disease activity and clinical evaluations will be evaluated. Since AS and PsA might be diseases with a strong impact on the daily life of the participant, an evaluation will be performed to the effect of the disease on quality of life and work productivity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined) |
-29.15 | — |
| SECONDARY Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Separately) |
-30.47; -26.11 | — |
| SECONDARY Number of Participants Employed at Each Assessed Visit |
26; 14; 40; 86; 41; 127 | — |
| SECONDARY Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit |
24.29; 12.27; 20.39; 10.24; 5.39; 8.57 | — |
| SECONDARY Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit |
62.25; 57.25; 60.68; 39.59; 32.22; 37.27 | — |
| SECONDARY Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit |
55.45; 46.18; 52.30; 24.44; 26.18; 25.05 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis) |
1.34; 0.70; 0.70; 0.62; 0.54; 0.68 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis) |
5.85; 3.11; 3.29; 2.30; 2.08; 3.24 | — |
| SECONDARY Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis) |
1.21; 0.76; 0.59; 0.60; 0.61; 0.68 | — |
| SECONDARY Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis) |
4.37; 2.26; 2.17; 1.99; 1.99; 2.05 | — |
| SECONDARY Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis) |
34.5; 32.7; 27.3; 5.5; 0.0; 52.0 | — |
| SECONDARY Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis) |
6.85; 3.97; 3.18; 3.27; 3.09; 3.76 | — |
| SECONDARY Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time |
15.14; 12.77; 14.25; 8.23; 6.05; 7.41 | — |
| SECONDARY Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time |
2.36; 1.48; 2.08; 0.35; 0.81; 0.51 | — |
| SECONDARY Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time |
67.14; 59.35; 64.58; 24.92; 21.19; 23.62 | — |
| SECONDARY Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time |
67.53; 60.89; 65.36; 36.31; 30.42; 34.35 | — |
| SECONDARY Participant's Global Assessment of Pain VAS Scores Over Time |
70.17; 64.24; 68.23; 37.91; 29.60; 35.14 | — |
Eligibility Criteria
Inclusion Criteria
- Patient >= 18 years and <= 50 years
- Patient diagnosed with AS or PsA
- Patient to be initiated on adalimumab (according to the Marketing Authorization and Belgian reimbursement criteria)
- Patient willing to sign informed consent
Exclusion Criteria
- Any contraindication for adalimumab as specified in the corresponding Summary of Product Characteristics (SmPC)
- Patient previously treated with biologics
- Patient participating in other AbbVie-sponsored trials
Data sourced from ClinicalTrials.gov (NCT01845818). 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.