Clinical trial NCT01001182: Health Outcomes in Rheumatoid Arthritis in Greece
Official title: Rheumatoid Arthritis in Greece: The Economic Burden of the Disease and the Impact on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: observational
non-interventional
prospective
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-26
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older with confirmed RA diagnosis will be included in the study. The investigating physician must confirm RA diagnosis during the patient's visit.

Brief summary: 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.

Detailed description: The study will use a prevalence-based approach, recruiting patients at various stages of disease. Subjects will be enrolled sequentially as per their order of appearance at the site, until the maximum allowed number of subjects is reached at each site.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life
timeFrame: 1 year
measure: Resource utilization
timeFrame: 1 year
measure: Productivity losses
timeFrame: 1 year
Secondary outcomes:
measure: Functional ability
timeFrame: 1 year
Other outcomes:
Locations:
city: Herakleion
country: Greece
facility: Pfizer Investigational Site
state: Crete
city: Mezourlo
country: Greece
facility: Pfizer Investigational Site
state: Larissa
city: Rio
country: Greece
facility: Pfizer Investigational Site
state: Patras
city: Alexandroupoli
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Ioannina
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: