Overview

This trial is active, not recruiting.

Condition psoriatic arthritis
Sponsor AbbVie
Start date April 2015
End date March 2017
Trial size 130 participants
Trial identifier NCT02414633, P15-084

Summary

A special investigation (post marketing observational study (PMOS)/non-mandatory) of HUMIRA® will be performed for correlation between baseline and follow-up by clinical observation 24 weeks (planned visit time; before the start of treatment, and at 4, 12, 16, and 24 weeks, 4 data collection points) in Japanese psoriatic arthritis patients who are engaged in paid work.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Subjects with an exposure

Primary Outcomes

Measure
Change in Work Productivity and Activity Impairment (WPAI)
time frame: From Week 0 to Week 24

Secondary Outcomes

Measure
Change in Work Productivity and Activity Impairment (WPAI)
time frame: From Week 0 to Week 16
Change in absenteeism
time frame: From Week 0 to Week 24
Change in Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire
time frame: From Week 0 to Week 24
Change in Psoriasis Area Severity Index (PASI)
time frame: From Week 0 to Week 24
Change in Disease Activity Score (DAS28)
time frame: From Week 0 to Week 24
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
time frame: From Week 0 to Week 24
Change in Self-reported functional status using Health Assessed Questionnaire (HAQ)
time frame: From Week 0 to Week 24
Change in number of hours actually worked in last 7 days
time frame: From Week 0 to Week 24
Change in the presence or absence of spondylitis
time frame: From Week 0 to Week 24
Change in the presence or absence of dactylitis
time frame: From Week 0 to Week 24
Change in the presence or absence of enthesitis
time frame: From Week 0 to Week 24
Change in the presence or absence of nail psoriasis
time frame: From Week 0 to Week 24
Number of subjects with serious adverse events
time frame: Up to week 24
Number of tender joints count(TJC) (0-68)
time frame: Up to week 24
Number of swollen joints count(SJC) (0-66)
time frame: Up to week 24

Eligibility Criteria

Male or female participants from 16 years up to 99 years old.

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

Additional Information

Official title Special Investigation (Working Productivity and Activity Impairment / WPAI in Japanese Patients With Psoriatic Arthritis / PsA)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.