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

• ClinicalTrials.gov Identifier: NCT02414633
• Recruitment Status: Completed
• First Posted: April 13, 2015
• Results First Posted: October 16, 2018
• Last Update Posted: October 16, 2018
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

Brief Summary:

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

Condition or disease
Psoriatic Arthritis

Study Design

• Study Type: Observational
• Actual Enrollment: 148 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Special Investigation (Working Productivity and Activity Impairment in Japanese Patients With Psoriatic Arthritis)
• Actual Study Start Date: April 1, 2015
• Actual Primary Completion Date: March 13, 2017
• Actual Study Completion Date: March 13, 2017

Groups and Cohorts

Group/Cohort
Humira; Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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 .
17. 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).

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: Sarina Kurimoto, MD; AbbVie GK.

  Study Documents (Full-Text)

Documents provided by AbbVie:

Study Protocol and Statistical Analysis Plan  [PDF] February 23, 2016

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nakagawa H, Tanaka Y, Sano S, Kameda H, Taniguchi A, Kashiwagi T, Kawaberi T, Kimura J, Morita A. Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis. Adv Ther. 2019 Mar;36(3):691-707. doi: 10.1007/s12325-018-0866-y. Epub 2019 Jan 19.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02414633
• Other Study ID Numbers: P15-084
• First Posted: April 13, 2015
• Results First Posted: October 16, 2018
• Last Update Posted: October 16, 2018
• Last Verified: October 2018

Keywords provided by AbbVie:

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