To Observe the Impacts of Anti-Tumor Necrosis Factor (TNF) Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— PsA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028169
• Other study ID #: P13-518
• Status: Completed
• Phase: N/A
• First received: January 3, 2014
• Last updated: April 6, 2016
• Start date: January 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of HealthTurkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This post marketing observational study (PMOS) is designed to provide the initial data on work impairment of Psoriatic Arthritis (PsA) patients in Turkey, as well as changes in work impairment, life quality and clinical response during treatment with anti-TNF agents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 first visit

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Work Productivity

Locations

Country	Name	City	State
Turkey	Site Reference ID/Investigator# 98055	Ankara
Turkey	Site Reference ID/Investigator# 98079	Ankara
Turkey	Site Reference ID/Investigator# 119219	Antalya
Turkey	Site Reference ID/Investigator# 126114	Edirne
Turkey	Site Reference ID/Investigator# 98056	Elazig
Turkey	Site Reference ID/Investigator# 98059	Eskisehir
Turkey	Site Reference ID/Investigator# 98078	Gaziantep
Turkey	Site Reference ID/Investigator# 98075	Gorukle, Bursa
Turkey	Site Reference ID/Investigator# 98080	Istanbul
Turkey	Site Reference ID/Investigator# 98060	Izmir
Turkey	Site Reference ID/Investigator# 126113	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the impact of long term treatment of psoriatic arthritis with anti-TNFs on Absenteeism	To collect the number of missed working days and the number of working days	Up to Month 9	No
Primary	Evaluation of the impact of long term treatment of psoriatic arthritis with anti-TNFs on Presenteeism	To collect the number of working days and the total number of working days	Up to Month 9	No
Primary	Evaluation of the impact of long term treatment of psoriatic arthritis with anti-TNFs on work productivity	To collect overall work impairment	Up to Month 9	No
Primary	Evaluation of the impact of long term treatment of psoriatic arthritis with anti-TNFs on total daily activity impairment	To collect total daily activity impairment by Work Productivity and Activity Impairment (WPAI) questionnaire	Up to Month 9	No
Secondary	To collect Self-reported functional status using Health Assessed Questionnaire (HAQ) questionnaire	To evaluate Self-reported functional status (disability)	Up to Month 9	No
Secondary	Evaluation of the Anti-TNF treatment effectiveness based percentage of patients achieving American College Rheumatology (ACR) 20/ACR50	To evaluate the effectiveness of Anti-TNF treatment	Up to Month 9	No
Secondary	Evaluation of the Anti-TNF treatment effectiveness based percentage of patients achieving ACR 70	To evaluate the effectiveness of Anti-TNF treatment	Up to Month 9	No
Secondary	Change in Disease Activity Score (DAS 28)	To evaluate the effectiveness of Anti-TNF treatment	Up to 9 months	No
Secondary	Change in Maastricht Ankylosing Spondylitis Enthesitis Score	To evaluate the effectiveness of Anti-TNF treatment	Up to 9 months	No
Secondary	Change in dactylytis	To evaluate the effectiveness of Anti-TNF treatment	Up to Month 9	No
Secondary	Number of swollen and/or tender joints	To evaluate the effectiveness of Anti-TNF treatment	Up to Month 9	No
Secondary	Change in levels of rheumatoid factor	To evaluate the effectiveness of Anti-TNF treatment	Up to Month 9	No
Secondary	Change in Erythrocyte Sedimentation Rate (ESR)	To evaluate the effectiveness of Anti-TNF treatment	Up to Month 9	No
Secondary	Change in C-reactive protein (CRP)	To evaluate the effectiveness of Anti-TNF treatment	Up to Month 9	No
Secondary	Change in Visual Analog Scale (VAS)	To collect physician's and patient's global assessment of disease activity and disease related pain and fatigue to evaluate the effectiveness of Anti-TNF treatment	Up to Month 9	No
Secondary	Number of patients with serious adverse events	To report serious adverse events (SAE) occurring during treatment with anti-TNF agents	Up to Month 9	Yes

External Links

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