This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02028169
First received: January 3, 2014
Last updated: March 16, 2017
Last verified: March 2017
  Purpose
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.

Condition
Psoriatic Arthritis Work Productivity

Study Type: Observational
Study Design: Observational Model: Other
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:
  • Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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.

  • WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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.

  • WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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.

  • WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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.


Secondary Outcome Measures:
  • Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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).

  • Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9 [ Time Frame: 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).

  • Disease Activity Score (DAS 28) Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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

  • Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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.

  • Dactylitis Score Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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).

  • Number of Swollen Joints Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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.

  • Number of Tender Joints Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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.

  • Levels of Rheumatoid Factor [ Time Frame: Up to Month 9 ]
  • Erythrocyte Sedimentation Rate (ESR) Up to Month 9 [ Time Frame: Up to Month 9 ]
    ESR values were measured as an inflammatory parameter. Low ESR values mean less inflammation.

  • C-reactive Protein (CRP) Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.

  • Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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).

  • Physician's Global Assessment of Disease Activity VAS Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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).

  • Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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).

  • Participant's Assessment of Total Back Pain VAS Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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).

  • Participant's Assessment of Pain and Fatigue VAS Up to Month 9 [ Time Frame: Baseline, Month 3, Month 6, 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).

  • Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9 [ Time Frame: 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.


Enrollment: 120
Study Start Date: January 2014
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants Receiving Anti-TNF for PsA
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 hospitals or Ministry of Health of Turkey training and research hospitals in Turkey.
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
  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

Sponsors and Collaborators
AbbVie
Investigators
Study Director: Mahmut Gücük, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02028169     History of Changes
Other Study ID Numbers: P13-518
Study First Received: January 3, 2014
Results First Received: March 16, 2017
Last Updated: March 16, 2017

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

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

ClinicalTrials.gov processed this record on July 27, 2017