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

Rheumatoid Arthritis Clinical Trial

Official title:
Special Investigation (Working Productivity and Activity Impairment / WPAI in Japanese Patients With Rheumatoid Arthritis / RA)

Clinical Trial Summary

Study Objectives

As special investigation (PMOS/non-mandatory) of HUMIRA® subcutaneous injection 40 mg syringe 0.8 mL (generic name: Adalimumab) will be performed to examine the following (1) and (2) for correlation between baseline and follow-up by clinical observation 48 weeks (planned visit time; before the start of treatment, and at 12, 24, 36, and 48 weeks, 4 data collection points) in Japanese rheumatoid arthritis patients who are engaged in paid work and home work.

1. The primary objective; Situation of work productivity using the Work Productivity and Activity Impairment/General Health questionnaire and functional impairment (daily life activity) using the Modified Health Assessment Questionnaire when HUMIRA® treatment.

2. The secondary objective; Clinical observation and rate of improvement of the Disease Activity Score 28 when HUMIRA® treatment. Situation of the occurrence of adverse events definition during the course of the observation period while HUMIRA® treatment, other factors considered to affect the safety and effectiveness.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01346488
Study type Observational
Source AbbVie
Contact
Status Completed
Phase N/A
Start date June 2011
Completion date January 2016
View Details
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