Special Investigation in Patients With Psoriatic Arthritis (PsA) (Working Productivity and Activity Impairment [WPAI])

October 15, 2018 updated by: AbbVie

Special Investigation (Working Productivity and Activity Impairment in Japanese Patients With Psoriatic Arthritis)

A special investigation (post marketing observational study [PMOS]/non-mandatory) of HUMIRA® in Japanese psoriatic arthritis patients who are engaged in paid work.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a single-arm, multi-center study with a prospective cohort.

Description

Inclusion Criteria:

  • Paid workers (including part-time) with Psoriatic Arthritis, who have never administered adalimumab, and are diagnosed by ClASsification of Psoriatic ARthritis (CASPAR) criteria

Exclusion Criteria:

  • Subjects showing decreased basic activities of daily life such as hospitalization and bedridden
  • Subjects with contraindications to adalimumab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Humira
Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Work Productivity and Activity Impairment Psoriatic Arthritis Questionnaire (WPAI:PsA) Percentage of Overall Work Impairment (OWI): Change From Baseline to Week 24
Time Frame: Baseline (Week 0), Week 24
WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Percentage of overall work impairment due to PsA (OWI) is calculated as: Absenteeism + (1 - Absenteeism) * Presenteeism. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 16
Time Frame: Baseline (Week 0), Week 4, Week 12, and Week 16
WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Percentage of overall work impairment due to PsA (OWI) is calculated as: Absenteeism + (1 - Absenteeism) * Presenteeism. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 4, Week 12, and Week 16
WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24
Time Frame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to PsA) is calculated as the number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked) * 100. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 4, Week 12, Week 16, and 24
WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24
Time Frame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to PsA) is calculated as the patient's rating of how much PsA affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 * 100. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 4, Week 12, Week 16, and 24
WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24
Time Frame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to PsA) is calculated as the patient's rating of how much PsA affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 * 100. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 4, Week 12, Week 16, and 24
Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24
Time Frame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
The PASE is a patient-administered questionnaire used to screen patients with psoriasis for evidence of psoriatic arthritis. The PASE consists of 15 questions divided into 2 subscales (system sub-scale and function sub-scale); 7 questions assess symptoms and 8 questions assess function. Questions are scored on a numeric scale ranging from 1 (strongly disagree) to 5 (strongly agree), with a total possible PASE score of 15 to 75. Individuals who are more likely to have PsA will score higher than individuals without PsA. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 4, Week 12, Week 16, and 24
Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 16 and 24
Time Frame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on of the lesions rated on a a scale from 0 (no symptoms) to 4 (very marked), together with the percentage of the area affected, rated on a scale from 0 (0%) to 6 (100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 4, Week 12, Week 16, and 24
Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 16 and 24
Time Frame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
DAS28 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 4, Week 12, Week 16, and 24
Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 16 and 24
Time Frame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
DAS28 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 4, Week 12, Week 16, and 24
Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 16 and 24
Time Frame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 4, Week 12, Week 16, and 24
Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 16 and 24
Time Frame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 4, Week 12, Week 16, and 24
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Change From Baseline to Weeks 12 and 24
Time Frame: Baseline (Week 0), Week 12, and Week 24
The BASDAI uses a scale from 1 (no problem) to 10 (worst problem) to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, and morning stiffness severity. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score ranging from 0-10. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 12, and Week 24
Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline to Weeks 12 and 24
Time Frame: Baseline (Week 0), Week 12, and Week 24
The HAQ-DI is a patient-reported outcome which is usually self-administered by the patient. The HAQ-DI assesses the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. The patients report the amount of difficulty they have in performing these activities using a scale ranging from 0 (can be performed without any difficulty) to 3 (cannot be done at all). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
Baseline (Week 0), Week 12, and Week 24
Enthesitis: Change From Baseline to Final Visit
Time Frame: Baseline (Week 0) and final visit (up to 24 weeks)
The percentage of participants with enthesitis.
Baseline (Week 0) and final visit (up to 24 weeks)
Dactylitis: Change From Baseline to Final Visit
Time Frame: Baseline (Week 0) and final visit (up to 24 weeks)
The percentage of participants with dactylitis.
Baseline (Week 0) and final visit (up to 24 weeks)
Spondylitis: Change From Baseline to Final Visit
Time Frame: Baseline (Week 0) and final visit (up to 24 weeks)
The percentage of participants with spondylitis.
Baseline (Week 0) and final visit (up to 24 weeks)
Nail Psoriasis: Change From Baseline to Final Visit
Time Frame: Baseline (Week 0) and final visit (up to 24 weeks)
The percentage of participants with nail psoriasis .
Baseline (Week 0) and final visit (up to 24 weeks)
Number of Participants With Adverse Events (AEs)
Time Frame: From the first dose of study drug until the end of the study (up to 24 weeks)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probable, possible, not related, or impossible to judge. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the physician obtained the patient's authorization or informed consent until the end of the study (week 28 or discontinuation).
From the first dose of study drug until the end of the study (up to 24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sarina Kurimoto, MD, AbbVie GK.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P15-084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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