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

Psoriatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414633
• Other study ID #: P15-084
• Status: Completed
• Start date: April 1, 2015
• Est. completion date: March 13, 2017

Study information

• Verified date: October 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: March 13, 2017
• Est. primary completion date: March 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work Productivity and Activity Impairment Psoriatic Arthritis Questionnaire (WPAI:PsA) Percentage of Overall Work Impairment (OWI): Change From Baseline to 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	WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 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
Secondary	WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 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
Secondary	WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 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
Secondary	WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 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
Secondary	Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 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
Secondary	Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 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
Secondary	Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 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
Secondary	Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 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
Secondary	Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 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
Secondary	Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 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
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Change From Baseline to Weeks 12 and 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
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline to Weeks 12 and 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
Secondary	Enthesitis: Change From Baseline to Final Visit	The percentage of participants with enthesitis.	Baseline (Week 0) and final visit (up to 24 weeks)
Secondary	Dactylitis: Change From Baseline to Final Visit	The percentage of participants with dactylitis.	Baseline (Week 0) and final visit (up to 24 weeks)
Secondary	Spondylitis: Change From Baseline to Final Visit	The percentage of participants with spondylitis.	Baseline (Week 0) and final visit (up to 24 weeks)
Secondary	Nail Psoriasis: Change From Baseline to Final Visit	The percentage of participants with nail psoriasis .	Baseline (Week 0) and final visit (up to 24 weeks)
Secondary	Number of Participants With Adverse Events (AEs)	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)

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