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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02028169
First received: January 3, 2014
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition
Psoriatic Arthritis
Work Productivity

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: To Observe the Impacts of Anti-TNF's Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Evaluation of the impact of long term treatment of psoriatic arthritis with anti-TNFs on Absenteeism [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To collect the number of missed working days and the number of working days

  • Evaluation of the impact of long term treatment of psoriatic arthritis with anti-TNFs on Presenteeism [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To collect the number of working days and the total number of working days

  • Evaluation of the impact of long term treatment of psoriatic arthritis with anti-TNFs on work productivity [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To collect overall work impairment

  • Evaluation of the impact of long term treatment of psoriatic arthritis with anti-TNFs on total daily activity impairment [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To collect total daily activity impairment by Work Productivity and Activity Impairment (WPAI) questionnaire


Secondary Outcome Measures:
  • To collect Self-reported functional status using Health Assessed Questionnaire (HAQ) questionnaire [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To evaluate Self-reported functional status (disability)

  • Evaluation of the Anti-TNF treatment effectiveness based percentage of patients achieving American College Rheumatology (ACR) 20/ACR50 [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Anti-TNF treatment

  • Evaluation of the Anti-TNF treatment effectiveness based percentage of patients achieving ACR 70 [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Anti-TNF treatment

  • Change in Disease Activity Score (DAS 28) [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Anti-TNF treatment

  • Change in Maastricht Ankylosing Spondylitis Enthesitis Score [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Anti-TNF treatment

  • Change in dactylytis [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Anti-TNF treatment

  • Number of swollen and/or tender joints [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Anti-TNF treatment

  • Change in levels of rheumatoid factor [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Anti-TNF treatment

  • Change in Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Anti-TNF treatment

  • Change in C-reactive protein (CRP) [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Anti-TNF treatment

  • Change in Visual Analog Scale (VAS) [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    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

  • Number of patients with serious adverse events [ Time Frame: Up to Month 9 ] [ Designated as safety issue: Yes ]
    To report serious adverse events (SAE) occurring during treatment with anti-TNF agents


Estimated Enrollment: 125
Study Start Date: January 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Psoriatic Arthritis patients treated with Anti-TNF
Psoriatic Arthritis patients treated with Anti-TNF

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients from both genders will be included to this non-interventional epidemiological study from selected university or state hospital or Ministry of Health of Turkey training and research hospitals in Turkey.

Criteria

Inclusion Criteria:

  1. Actively working, either full-time or part-time
  2. Previous confirmed diagnosis of PsA by a rheumatologist
  3. Patients for whom the physician has initiated PsA treatment with an Anti-TNF in accordance with Turkish Ministry of Health regulations and reimbursement criteria
  4. Able to provide authorization to use and disclose their health related information

Exclusion Criteria:

  1. Patients with a history of an allergic reaction or significant sensitivity to anti-TNF agents
  2. 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
  3. Patients participating in any clinical trial of an experimental drug 30 days prior to the first visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028169

Contacts
Contact: Imge Guneshan, BS Pharm +90 216 636 0600 imge.guneshan@abbvie.com
Contact: Senem Gülcü Kurtis, BS Pharm +90 216 636 0600 senem.kurtis@abbvie.com

Locations
Turkey
Site Reference ID/Investigator# 119217 Not yet recruiting
Adana, Turkey
Principal Investigator: Site Reference ID/Investigator# 119217         
Site Reference ID/Investigator# 98079 Not yet recruiting
Ankara, Turkey
Principal Investigator: Site Reference ID/Investigator# 98079         
Site Reference ID/Investigator# 126115 Not yet recruiting
Ankara, Turkey, 06500
Principal Investigator: Site Reference ID/Investigator# 126115         
Site Reference ID/Investigator# 98055 Not yet recruiting
Ankara, Turkey, 06100
Principal Investigator: Site Reference ID/Investigator# 98055         
Site Reference ID/Investigator# 119219 Not yet recruiting
Antalya, Turkey, 07058
Principal Investigator: Site Reference ID/Investigator# 119219         
Site Reference ID/Investigator# 98075 Recruiting
Bursa, Turkey, 16059
Principal Investigator: Site Reference ID/Investigator# 98075         
Site Reference ID/Investigator# 126114 Recruiting
Edirne, Turkey, 22030
Principal Investigator: Site Reference ID/Investigator# 126114         
Site Reference ID/Investigator# 98056 Not yet recruiting
Elazig, Turkey, 23119
Principal Investigator: Site Reference ID/Investigator# 98056         
Site Reference ID/Investigator# 98059 Not yet recruiting
Eskisehir, Turkey, 26480
Principal Investigator: Site Reference ID/Investigator# 98059         
Site Reference ID/Investigator# 98078 Not yet recruiting
Gaziantep, Turkey
Principal Investigator: Site Reference ID/Investigator# 98078         
Site Reference ID/Investigator# 67502 Withdrawn
Istanbul, Turkey
Site Reference ID/Investigator# 98080 Not yet recruiting
Istanbul, Turkey
Principal Investigator: Site Reference ID/Investigator# 98080         
Site Reference ID/Investigator# 98077 Withdrawn
Istanbul, Turkey
Site Reference ID/Investigator# 98060 Recruiting
Izmir, Turkey
Principal Investigator: Site Reference ID/Investigator# 98060         
Site Reference ID/Investigator# 98057 Not yet recruiting
Konya, Turkey, 42075
Principal Investigator: Site Reference ID/Investigator# 98057         
Site Reference ID/Investigator# 98076 Not yet recruiting
Mersin, Turkey, 33050
Principal Investigator: Site Reference ID/Investigator# 98076         
Site Reference ID/Investigator# 98058 Withdrawn
Sakarya, Turkey, 41380
Site Reference ID/Investigator# 126113 Not yet recruiting
Samsun, Turkey, 55139
Principal Investigator: Site Reference ID/Investigator# 126113         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Mahmut Gucuk, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02028169     History of Changes
Other Study ID Numbers: P13-518
Study First Received: January 3, 2014
Last Updated: July 22, 2014
Health Authority: Turkey: Ethics Committee
Turkey: Ministry of Health

Keywords provided by AbbVie:
Psoriatic Arthritis
Anti-TNFs
Work Productivity

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis

ClinicalTrials.gov processed this record on October 20, 2014