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

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01346488

P12-772

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,088 patients

Sex: All

Ages: 15 to 87 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,088 participants in 1 patient group

Adalimumab

Description:

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).