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)

Study Overview
=================
Brief 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.

Official Title
-----------------
To Observe the Impacts of Anti-TNF's Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis

Conditions
-----------------
Psoriatic Arthritis, Work Productivity

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Receiving Anti-TNF for PsA<br>Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9 | Absenteeism, presented as the mean percentage of work time missed due to PsA (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | Baseline, Month 3, Month 6, Month 9 | 
| WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9 | Presenteeism (the extent to which PsA decreased productivity) is presented as the mean percentage of impairment while working due to PsA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | Baseline, Month 3, Month 6, Month 9 | 
| WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9 | The mean percentage of OWPI due to PsA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) +[1- Absenteeism(%)*Presenteeism(%)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | Baseline, Month 3, Month 6, Month 9 | 
| WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9 | Activity impairment due to PsA (the extent to which PsA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | Baseline, Month 3, Month 6, Month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9 | The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide a total score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). | Baseline, Month 3, Month 6, Month 9 | 
| Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9 | A participant is an ACR20, ACR50, or ACR70 responder if the following 3 criteria for improvement from Baseline are met: ≥ 20%, ≥ 50%, or ≥ 70% improvement in tender joint count; ≥ 20%, ≥ 50%, or ≥ 70% improvement in swollen joint count; and ≥ 20%, ≥ 50%, or ≥ 70% improvement in at least 3 of the 5 following parameters: Physician's global assessment of disease activity Participant's global assessment of disease activity Participant's assessment of pain HAQ-DI Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein). | Month 9 | 
| Disease Activity Score (DAS 28) Up to Month 9 | The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Participants were classified according to their scores as below: DAS28 > 5.1 = High disease activity DAS28 < 3.2 = Low disease activity DAS28 < 2.6 = Remission | Baseline, Month 3, Month 6, Month 9 | 
| Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9 | For calculation of the enthesitis (tenderness) score, MASES was used in practice by the physicians. This scale takes into account the sites (first costochondral joint, seventh costochondral joint, posterior superior iliac spine, anterior superior iliac spine, iliac crest, fifth lumbar spinous process and proximal insertion of the Achilles tendon) and they scored from 0 to 13. Minimum tenderness score was 0; maximum tenderness score was 13. | Baseline, Month 3, Month 6, Month 9 | 
| Dactylitis Score Up to Month 9 | A total of 20 digits were assessed as entire digits, looking for signs of tender dactylitis. Dactylitis is defined as a uniform swelling of the digits where the joints cannot be defined. Investigators entered scores between 0 (no swelling or pain) and 6 (most severe swelling and pain). | Baseline, Month 3, Month 6, Month 9 | 
| Number of Swollen Joints Up to Month 9 | Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints. | Baseline, Month 3, Month 6, Month 9 | 
| Number of Tender Joints Up to Month 9 | Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints. | Baseline, Month 3, Month 6, Month 9 | 
| Levels of Rheumatoid Factor |  | Up to Month 9 | 
| Erythrocyte Sedimentation Rate (ESR) Up to Month 9 | ESR values were measured as an inflammatory parameter. Low ESR values mean less inflammation. | Up to Month 9 | 
| C-reactive Protein (CRP) Up to Month 9 | CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation. | Baseline, Month 3, Month 6, Month 9 | 
| Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9 | A VAS was used to measure the participant's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor). | Baseline, Month 3, Month 6, Month 9 | 
| Physician's Global Assessment of Disease Activity VAS Up to Month 9 | A VAS was used to measure the physician's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor). | Baseline, Month 3, Month 6, Month 9 | 
| Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9 | A VAS was used to measure the participant's assessment of nocturnal back pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor). | Baseline, Month 3, Month 6, Month 9 | 
| Participant's Assessment of Total Back Pain VAS Up to Month 9 | A VAS was used to measure the participant's assessment of back pain. For this assessment a 10-point scale was used (0: very well; 10: very poor). | Baseline, Month 3, Month 6, Month 9 | 
| Participant's Assessment of Pain and Fatigue VAS Up to Month 9 | A VAS was used to measure the participant's assessment of pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor). | Baseline, Month 3, Month 6, Month 9 | 
| Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9 | Number of participants with any serious adverse event (SAE) occurring during treatment with anti-TNF agents and/or participants who discontinued treatment due to SAEs or AEs which were caused by the treatment with anti-TNF agents during the course of treatment. An SAE is defined as an event that: results in the death; is life-threatening; results in an admission to the hospital or prolongation of hospitalization; is a congenital anomaly; results in a condition that substantially interferes with the activities of daily living of a study subject; is an important medical event according to the Investigator. | Up to Month 9 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Work Productivity, Anti-TNFs, Psoriatic Arthritis