Special Investigation in Patients With Rheumatoid Arthritis (Working Productivity Activity Impairment)

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2088 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-01-31

Brief Summary

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This is a single-arm, multi-center, prospective cohort study (post-marketing observational study). The observation period for each participant is 48 weeks.

This study is designed to provide additional data on treatment effects of adalimumab during 48 weeks of treatment in patients with RA under conditions of routine rheumatology care. Course of work productivity and work ability, the course of health-related quality of life, and changes in functionality during 48 weeks treatment with adalimumab are to be documented.

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Detailed Description

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This study was designed as a non-interventional observational study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adalimumab

Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

RA patients treated with adalimumab who satisfied the following conditions:

1. Paid worker (PW) RA patients who are engaged in paid work for more than 35 hours per week
2. Home worker (HW)

* Category 1 unpaid workers; RA patients who are engaged in paid work for less than 35 hours per week
* Category 2 unpaid workers; RA patients who perform basic activities of daily life (household duties, shopping, child caring, exercise, study, etc.) other than PW

Exclusion Criteria

1. RA patients showing lowered basic activities of daily life, such as hospitalization and being bedridden
2. RA patients with a history of previous treatment with adalimumab

Minimum Eligible Age

15 Years

Maximum Eligible Age

87 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No