CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 124 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01078116
NCT01078116N/ACompleted

Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis

Abbott·observational·Posted Mar 2, 2010·Updated Aug 11, 2011

In Brief

An observational study for Rheumatoid Arthritis. Completed, enrolled 124 participants across 10 sites.

Detailed Summary

Evaluation of Health Related Quality of Life (HRQL) is of a paramount importance in assessing the impact of rheumatoid arthritis on patients' health status, however when costs associated with rheumatoid arthritis are also taken into account, the information provided may lead to a more balanced view in analyzing the treatment of the disease. In accordance with the above, the main objective this study was to evaluate the impact of adalimumab treatment not only on patients' Health Related Quality of Life but also on the cost of the disease management. In order to accomplish this the study has been focused on: 1. Estimating the direct and indirect cost incurred by adalimumab treatment. 2. Measuring the Health Related Quality of Life of rheumatoid arthritis patients under adalimumab treatment. 3. Exploring the cost-utility relationship of rheumatoid arthritis patients treated with adalimumab by combining the Health Related Quality of Life of rheumatoid arthritis patients and direct as well as indirect costs due to RA. More specifically, data related to patients' Health Related Quality of Life and cost associated with rheumatoid arthritis will be recorded for one-year period, and collected at four subsequent visits: baseline, month 3, 6 and 12. The visit before starting treatment with adalimumab will be considered as baseline. This information was used to compare Health Related Quality of Life and cost data before and after adalimumab initiation and therefore identify the effect of adalimumab treatment in patients with rheumatoid arthritis.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGreece

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2, 2010
Enrollment StartNov 1, 2007
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.3 years ago