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Psoriatic ArthritisNCT02028169

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)

An observational study of Psoriatic Arthritis and Work Productivity, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Psoriatic Arthritis, Work Productivity
How many people
120 participants
Where
No sites listed yet
Study dates
Jan 2014to Apr 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Keywords
Work Productivity, Anti-TNFs, Psoriatic Arthritis
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02028169
Study groupRoleWhat they receive
Participants Receiving Anti-TNF for PsAParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Month 3, Month 6, Month 9

  2. 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.

    Measured: Baseline, Month 3, Month 6, Month 9

  3. 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.

    Measured: Baseline, Month 3, Month 6, Month 9

  4. 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.

    Measured: Baseline, Month 3, Month 6, Month 9

Secondary outcomes (16)

  1. 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).

    Measured: Baseline, Month 3, Month 6, Month 9

  2. 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).

    Measured: Month 9

  3. 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

    Measured: Baseline, Month 3, Month 6, Month 9

  4. 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.

    Measured: Baseline, Month 3, Month 6, Month 9

  5. 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).

    Measured: Baseline, Month 3, Month 6, Month 9

  6. 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.

    Measured: Baseline, Month 3, Month 6, Month 9

  7. 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.

    Measured: Baseline, Month 3, Month 6, Month 9

  8. Levels of Rheumatoid Factor

    Measured: Up to Month 9

  9. Erythrocyte Sedimentation Rate (ESR) Up to Month 9

    ESR values were measured as an inflammatory parameter. Low ESR values mean less inflammation.

    Measured: Up to Month 9

  10. C-reactive Protein (CRP) Up to Month 9

    CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.

    Measured: Baseline, Month 3, Month 6, Month 9

  11. 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).

    Measured: Baseline, Month 3, Month 6, Month 9

  12. 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).

    Measured: Baseline, Month 3, Month 6, Month 9

  13. 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).

    Measured: Baseline, Month 3, Month 6, Month 9

  14. 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).

    Measured: Baseline, Month 3, Month 6, Month 9

  15. 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).

    Measured: Baseline, Month 3, Month 6, Month 9

  16. 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.

    Measured: Up to Month 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02028169
Sponsor's protocol ID
P13-518
Status last verified
Mar 2017
First submitted
3 Jan 2014
Last updated
27 Apr 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 34477993

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriatic Arthritis and Work Productivity, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02028169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.

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