Clinical trial NCT02028169: 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)
Official title: To Observe the Impacts of Anti-TNF's Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Work Productivity
Keywords: Work Productivity
Anti-TNFs
Psoriatic Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from both genders will be included to this non-interventional epidemiological study from selected university or state hospitals or Ministry of Health of Turkey training and research hospitals in Turkey.

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.


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

Primary outcomes:
measure: Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
Secondary outcomes:
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9
timeFrame: Month 9
measure: Disease Activity Score (DAS 28) Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Dactylitis Score Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Number of Swollen Joints Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Number of Tender Joints Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Levels of Rheumatoid Factor
timeFrame: Up to Month 9
measure: Erythrocyte Sedimentation Rate (ESR) Up to Month 9
timeFrame: Up to Month 9
measure: C-reactive Protein (CRP) Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Physician's Global Assessment of Disease Activity VAS Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Participant's Assessment of Total Back Pain VAS Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Participant's Assessment of Pain and Fatigue VAS Up to Month 9
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9
timeFrame: Up to Month 9
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Mahmut Gücük, MD
role: STUDY_DIRECTOR
References:
citation: Karadag O, Dalkilic E, Ayan G, Kucuksahin O, Kasifoglu T, Yilmaz N, Koca SS, Yazisiz V, Erten PT, Sayarlioglu M, Terzioglu ME, Erten S, Kalyoncu U. Real-world data on change in work productivity, activity impairment, and quality of life in patients with psoriatic arthritis under anti-TNF therapy: a postmarketing, noninterventional, observational study. Clin Rheumatol. 2022 Jan;41(1):85-94. doi: 10.1007/s10067-021-05893-3. Epub 2021 Sep 3.