Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis (RA)
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.
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
Observational Model: Cohort, Time Perspective: Prospective
Site Reference ID/Investigator# 32070
Active, not recruiting
Results (where available)
- 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.
Antibodies found in adult RHEUMATOID ARTHRITIS patients that are directed against GAMMA-CHAIN IMMUNOGLOBULINS.
A butyl-diphenyl-pyrazolidinedione that has anti-inflammatory, antipyretic, and analgesic activities. It has been used in ANKYLOSING SPONDYLITIS; RHEUMATOID ARTHRITIS; and REACTIVE ARTHRITIS.
Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. Our study is aimed at looking at the effects of proven cholesterol lowering treatment drug called...
This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by patients with the disease.
The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.
This research is being done to help us learn about how different factors related to treatment affect rheumatoid arthritis (RA). This is not a treatment study. We will follow the patient fo...
The Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS 1) is designed to systematically collect and document use patterns, effectiveness, and safety of DMARD treatments...
araoxonase-1 (PON1) is a high-density lipoprotein-associated enzyme that exhibits antioxidant and antiatherogenic activities. We examined a possible association between T172A (L55M) and T(-107)C polym...
Does the p38 MAP kinase inhibitor pamapimod have potential for the treatment of rheumatoid arthritis? Evaluation of: Zhang X, Huang Y, Navarro M, et al. A proof-of-concept and drug-drug interaction of pamapimod, a novel p38 MAP kinase inhibitor, with meth
Methotrexate alone or in combination with other agents is the standard treatment for moderate-to-severe rheumatoid arthritis. As biological agents are expensive, they are not usually used until methot...
An oral Syk kinase inhibitor in the treatment of rheumatoid arthritis: A three-month randomized, placebo-controlled, phase II study in patients with active rheumatoid arthritis that did not respond to biologic agents.
To assess the efficacy and safety of R788 (fostamatinib disodium), an inhibitor of spleen tyrosine kinase (Syk), in patients with active rheumatoid arthritis (RA) that did not respond to biologic ther...
RATIONALE: Mortality rates from rheumatoid arthritis-associated interstitial lung disease are largely unknown. OBJECTIVES: We sought to determine mortality rates from rheumatoid arthritis-associated i...
Rheumatoid arthritis is an autoimmune disorder which involves inflammation of the synovial tissue, leading to synovial proliferation, bone erosion and ultimately joint disability. It is a complex diso...