Trials / Completed
CompletedNCT01346488
Special Investigation in Patients With Rheumatoid Arthritis (Working Productivity Activity Impairment)
The Documentation of the Effects on Quality of Life (QOL) and Working Productivity and Activity Impairment (WPAI) in Patients With Rheumatoid Arthritis (RA) Under HUMIRA® (Adalimumab) in Routine Clinical Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,088 (actual)
- Sponsor
- AbbVie (prior sponsor, Abbott) · Industry
- Sex
- All
- Age
- 15 Years – 87 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2011-05-03
- Last updated
- 2017-04-13
- Results posted
- 2017-03-03
Source: ClinicalTrials.gov record NCT01346488. Inclusion in this directory is not an endorsement.