N/A
Completed N=120
To Observe the Impacts of Anti-Tumor Necrosis Factor (TNF) Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis (PsA)
Rheumatoid Arthritis · Work Productivity
Source: ClinicalTrials.gov NCT02028169 ↗
Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Apr 2017
Primary outcomePrimary: Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9 — 20.5; 10.0; 7.9; 4.9 percentage of work time missed — p=< 0.001
Summary
This post marketing observational study is designed to provide the initial data on work impairment of PsA patients in Turkey, as well as changes in work impairment, life quality and clinical response during treatment with anti-TNF agents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9 |
20.5; 10.0; 7.9; 4.9 | < 0.001 sig |
| PRIMARY WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9 |
53.7; 26.5; 27.1; 19.5 | < 0.001 sig |
| PRIMARY WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9 |
42.8; 21.6; 21.0; 15.3 | < 0.001 sig |
| PRIMARY WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9 |
60.2; 35.3; 28.7; 23.0 | < 0.001 sig |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9 |
1.73; 1.24; 1.15; 1.08 | < 0.001 sig |
| SECONDARY Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9 |
13.2; 86.8; 36.3; 63.7; 58.2; 41.8 | — |
| SECONDARY Disease Activity Score (DAS 28) Up to Month 9 |
1; 6; 49; 62; 2; 32 | — |
| SECONDARY Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9 |
1.75; 0.60; 0.19; 0.45 | < 0.001 sig |
| SECONDARY Dactylitis Score Up to Month 9 |
0.47; 0.15; 0.06; 0.03 | < 0.001 sig |
| SECONDARY Number of Swollen Joints Up to Month 9 |
4.91; 1.99; 0.39; 0.54 | < 0.001 sig |
| SECONDARY Number of Tender Joints Up to Month 9 |
8.24; 3.91; 1.38; 1.92 | < 0.001 sig |
| SECONDARY Levels of Rheumatoid Factor |
— | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) Up to Month 9 |
6.46; 14.71; 14.28; 15.65 | < 0.001 sig |
| SECONDARY C-reactive Protein (CRP) Up to Month 9 |
19.73; 26.64; 5.89; 4.95 | — |
| SECONDARY Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9 |
6.73; 3.93; 3.04; 2.89 | < 0.001 sig |
| SECONDARY Physician's Global Assessment of Disease Activity VAS Up to Month 9 |
6.45; 3.49; 2.62; 2.26 | < 0.001 sig |
| SECONDARY Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9 |
5.57; 3.06; 2.58; 2.08 | < 0.001 sig |
| SECONDARY Participant's Assessment of Total Back Pain VAS Up to Month 9 |
5.25; 3.28; 2.47; 2.22 | < 0.001 sig |
| SECONDARY Participant's Assessment of Pain and Fatigue VAS Up to Month 9 |
6.37; 4.31; 2.91; 2.67 | < 0.001 sig |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9 |
1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Actively working, either full-time or part-time
- Previous confirmed diagnosis of PsA by a rheumatologist
- Patients for whom the physician has initiated PsA treatment with an Anti-TNF in accordance with Turkish Ministry of Health regulations and reimbursement criteria
- Able to provide authorization to use and disclose their health related information
Exclusion Criteria
- Patients with a history of an allergic reaction or significant sensitivity to anti-TNF agents
- Patients with possible follow-up problems during the planned study period or patients who may not be compliant to treatment as evaluated by the investigator/treating physician
- Patients participating in any clinical trial of an experimental drug 30 days prior to the baseline visit
Data sourced from ClinicalTrials.gov (NCT02028169). 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.