Rheumatoid Arthritis Clinical Trial
Official title:
Special Investigation (Working Productivity and Activity Impairment / WPAI in Japanese Patients With Rheumatoid Arthritis / RA)
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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