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

NCT ID: NCT02414633

Last Updated: 2018-10-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-01

Study Completion Date

2017-03-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriatic Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Humira

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarina Kurimoto, MD

Role: STUDY_DIRECTOR

AbbVie

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30661197 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P15-084

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.