N/A
N=148
Special Investigation in Patients With Psoriatic Arthritis (PsA) (Working Productivity and Activity Impairment [WPAI])
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02414633 ↗Enrolled (actual)
148
Serious AEs
2.7%
Results posted
Oct 2018
Primary outcome: Primary: Work Productivity and Activity Impairment Psoriatic Arthritis Questionnaire (WPAI:PsA) Percentage of Overall Work Impairment (OWI): Change From Baseline to Week 24 — 40.22; -25.24 percentage of OWI
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Work Productivity and Activity Impairment Psoriatic Arthritis Questionnaire (WPAI:PsA) Percentage of Overall Work Impairment (OWI): Change From Baseline to Week 24 |
40.22; -25.24 | — |
| SECONDARY WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 16 |
40.22; -16.35; -18.83; -25.91 | — |
| SECONDARY WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 |
8.41; -5.13; -4.96; -5.37; -4.90 | — |
| SECONDARY WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 |
37.5; -15.1; -16.2; -24.9; -24.3 | — |
| SECONDARY WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24 |
41.7; -17.4; -20.1; -25.0; -27.1 | — |
| SECONDARY Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24 |
47.4; -11.8; -14.5; -16.6; -18.1 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 16 and 24 |
8.97; -4.06; -5.14; -7.35; -6.63 | — |
| SECONDARY Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 16 and 24 |
3.77; -1.48; -1.83; -1.84; -2.13 | — |
| SECONDARY Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 16 and 24 |
4.25; -1.60; -1.99; -2.13; -2.57 | — |
| SECONDARY Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 16 and 24 |
7.2; -3.8; -4.8; -4.5; -6.2 | — |
| SECONDARY Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 16 and 24 |
5.3; -2.7; -3.9; -3.9; -4.9 | — |
| SECONDARY Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Change From Baseline to Weeks 12 and 24 |
4.203; -2.058; -2.745 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline to Weeks 12 and 24 |
0.5429; -0.2522; -0.3996 | — |
| SECONDARY Enthesitis: Change From Baseline to Final Visit |
36.8; 12.3 | — |
| SECONDARY Dactylitis: Change From Baseline to Final Visit |
55.7; 7.5 | — |
| SECONDARY Spondylitis: Change From Baseline to Final Visit |
29.2; 4.7 | — |
| SECONDARY Nail Psoriasis: Change From Baseline to Final Visit |
50.9; 29.2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
28; 4 | — |
Summary
A special investigation (post marketing observational study [PMOS]/non-mandatory) of HUMIRA® in Japanese psoriatic arthritis patients who are engaged in paid work.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02414633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.