Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis (RA) — HEOR  

Rheumatoid Arthritis Clinical Trial

Official title: Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis

Status Completed

Clinical Trial 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.

Clinical Trial Description

Data concerning patients' Health Related Quality of Life as well as the cost of the disease treatment were collected at four subsequent periods and specifically at baseline (Visit 1), and at months 3, 6 and 12.

Moreover, at baseline patients' socioeconomic, and history of illness data as well as the use of other prescribed medication and costs due to rheumatoid arthritis have been recorded, in order to identify patients' health state before adalimumab treatment initiation.

Patients discontinuing therapy (drop-outs) either due to adverse events or on their own initiative were categorized and analyzed separately, while reasons leading to discontinuation were recorded. Adverse events were not collected in this study with the exception of adverse events leading to withdrawal.

In order to evaluate the cost-utility of adalimumab both the cost of the disease treatment and the Health Related Quality of Life of rheumatoid arthritis patients have been taken into account. The process is described below:

Face-to-face interviews were conducted by the physicians/investigators in charge in all four subsequent periods as well as before adalimumab treatment initiation. A questionnaire, divided into the following sections, was administered: 1. Patients' Sociodemographic Characteristics 2. Measurement of Health Related Quality of Life in Rheumatoid Arthritis patients 3. Cost Assessment ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT01078116
• Study type: Observational
• Source: Abbott
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Completion date: June 2010