Rheumatoid Arthritis Clinical Trial
— HORAOfficial title:
Rheumatoid Arthritis in Greece: The Economic Burden of the Disease and the Impact on Quality of Life
Verified date | July 2014 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Observational |
Rheumatoid Arthritis (RA) is a chronic debilitating disease, causing severe pain and
progressive joint destruction and leading to partial loss of mobility. The disease has a
severe impact on patients' quality of life, due to the pain and physical impairment it
causes, which can also result in psychological and social difficulties. Moreover, the
chronic nature of the disease deems necessary the long-term use of medication, causing
significant costs to the patient and the healthcare system. The decline in functional
ability can cause problems at work, with reduced productivity or even unemployment. In
addition, RA can limit the patients' ability for self-care, hence imposing a further burden
on the patients' families and the society.
Many international studies have confirmed the reduced quality of life for people suffering
from RA [1-3], as well as the large economic impact of the disease on the patients, the
health system and society [4-6]. However, no assessment of the above impact of RA on the
Greek population has been published so far.
A wide research of the literature confirms the relationship between costs and quality of
life on the one hand and functional ability (as measured by the Health Assessment
Questionnaire) on the other hand. [7-8] The impact of functional ability on quality of life
is straightforward, however studies also demonstrate that as disease symptoms progress,
without proper treatment, the overall costs undertaken by the patient or the healthcare
system can rise significantly. On the other hand, if effective treatment can lessen or
postpone the most serious consequences of the disease (such as extensive joint damage that
could lead to surgical replacement), the savings on healthcare can offset some of the costs
of the more effective drug therapies.
In the light of the above findings, it seems important that in order to properly assess
therapeutic strategies for RA patients it is necessary to have an accurate view of the total
burden of RA on the population. It is also important to be able to establish a robust
relationship between functional ability and impact of RA on costs and quality of life.
Status | Completed |
Enrollment | 210 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects aged 18 years or older - Confirmed diagnosis of theumatoid arthritis by investigating physician. - Evidence of a personally signed and dated informed consent document (or legally acceptable representative). Exclusion Criteria: - Simultaneous participation in an interventional clinical trial. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | Pfizer Investigational Site | Alexandroupoli | |
Greece | Pfizer Investigational Site | Athens | |
Greece | Pfizer Investigational Site | Herakleion | Crete |
Greece | Pfizer Investigational Site | Ioannina | |
Greece | Pfizer Investigational Site | Mezourlo | Larissa |
Greece | Pfizer Investigational Site | Rio | Patras |
Greece | Pfizer Investigational Site | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life | 1 year | No | |
Primary | Resource utilization | 1 year | No | |
Primary | Productivity losses | 1 year | No | |
Secondary | Functional ability | 1 year | No |
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