Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis (RA)
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 of our study will be 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 that we will focus on:
1. Estimating the cost and specifically 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.As baseline will be considered the visit before starting treatment with Adalimumab.That will contribute at comparing Health Related Quality of Life and cost data before and after Adalimumab initiation and therefore identifying the effect of Adalimumab treatment in patients with Rheumatoid Arthritis.
Description
Data concerning patients' Health Related Quality of Life as well as the cost of the disease treatment will be administrated 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 will be 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 will be categorized and analyzed separately, while reasons leading to discontinuation will be recorded.
In order to evaluate the cost-utility of Adalimumab we will take into account both the cost of the disease treatment and the Health Related Quality of Life of Rheumatoid Arthritis patients. The process, which is intended to be followed is described upon below:
Face-to-face interviews will be conducted by the physicians/investigators in charge in all four subsequent periods as well as before Adalimumab treatment initiation. A questionnaire, designed especially for the objectives of the study and divided into the following sections will be used: 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
Conditions
Rheumatoid Arthritis
Location
Site Reference ID/Investigator# 32070
Athens
Greece
11521
Status
Active, not recruiting
Source
Abbott
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01078116
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Arthritis, Juvenile Rheumatoid
Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.
Gold Sodium Thiomalate
A variable mixture of the mono- and disodium salts of gold thiomalic acid used mainly for its anti-inflammatory action in the treatment of rheumatoid arthritis. It is most effective in active progressive rheumatoid arthritis and of little or no value in the presence of extensive deformities or in the treatment of other forms of arthritis.
Still's Disease, Adult-onset
Systemic-onset rheumatoid arthritis in adults. It differs from classical rheumatoid arthritis in that it is more often marked by acute febrile onset, and generalized lymphadenopathy and hepatosplenomegaly are more prominent.
Rheumatoid Factor
Antibodies found in adult RHEUMATOID ARTHRITIS patients that are directed against GAMMA-CHAIN IMMUNOGLOBULINS.
Phenylbutazone
A butyl-diphenyl-pyrazolidinedione that has anti-inflammatory, antipyretic, and analgesic activities. It has been used in ANKYLOSING SPONDYLITIS; RHEUMATOID ARTHRITIS; and REACTIVE ARTHRITIS.
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