NCT02414633

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 16, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

January 30, 2015

Results QC Date

February 9, 2018

Last Update Submit

October 15, 2018

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 16

    Baseline (Week 0), Week 4, Week 12, and Week 16

  • WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24

    Baseline (Week 0), Week 4, Week 12, Week 16, and 24

  • WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24

    Baseline (Week 0), Week 4, Week 12, Week 16, and 24

  • WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24

    Baseline (Week 0), Week 4, Week 12, Week 16, and 24

  • Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24

    Baseline (Week 0), Week 4, Week 12, Week 16, and 24

  • +12 more secondary outcomes

Study Arms (1)

Humira

Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Paid workers (including part-time) with Psoriatic Arthritis, who have never administered adalimumab, and are diagnosed by ClASsification of Psoriatic ARthritis (CASPAR) criteria

You may not qualify if:

  • Subjects showing decreased basic activities of daily life such as hospitalization and bedridden
  • Subjects with contraindications to adalimumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30661197DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • Sarina Kurimoto, MD

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

April 13, 2015

Study Start

April 1, 2015

Primary Completion

March 13, 2017

Study Completion

March 13, 2017

Last Updated

October 16, 2018

Results First Posted

October 16, 2018

Record last verified: 2018-10