Clinical trial NCT02414633: Special Investigation in Patients With Psoriatic Arthritis (PsA) (Working Productivity and Activity Impairment [WPAI])
Official title: Special Investigation (Working Productivity and Activity Impairment in Japanese Patients With Psoriatic Arthritis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-04-13
Enrollment: 148
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a single-arm, multi-center study with a prospective cohort.

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.


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

Primary outcomes:
measure: Work Productivity and Activity Impairment Psoriatic Arthritis Questionnaire (WPAI:PsA) Percentage of Overall Work Impairment (OWI): Change From Baseline to Week 24
timeFrame: Baseline (Week 0), Week 24
Secondary outcomes:
measure: WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 16
timeFrame: Baseline (Week 0), Week 4, Week 12, and Week 16
measure: WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24
timeFrame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
measure: WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24
timeFrame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
measure: WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24
timeFrame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
measure: Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24
timeFrame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
measure: Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 16 and 24
timeFrame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
measure: Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 16 and 24
timeFrame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
measure: Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 16 and 24
timeFrame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
measure: Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 16 and 24
timeFrame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
measure: Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 16 and 24
timeFrame: Baseline (Week 0), Week 4, Week 12, Week 16, and 24
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Change From Baseline to Weeks 12 and 24
timeFrame: Baseline (Week 0), Week 12, and Week 24
measure: Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline to Weeks 12 and 24
timeFrame: Baseline (Week 0), Week 12, and Week 24
measure: Enthesitis: Change From Baseline to Final Visit
timeFrame: Baseline (Week 0) and final visit (up to 24 weeks)
measure: Dactylitis: Change From Baseline to Final Visit
timeFrame: Baseline (Week 0) and final visit (up to 24 weeks)
measure: Spondylitis: Change From Baseline to Final Visit
timeFrame: Baseline (Week 0) and final visit (up to 24 weeks)
measure: Nail Psoriasis: Change From Baseline to Final Visit
timeFrame: Baseline (Week 0) and final visit (up to 24 weeks)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From the first dose of study drug until the end of the study (up to 24 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Sarina Kurimoto, MD
role: STUDY_DIRECTOR
References:
citation: 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.