Health Outcomes in Rheumatoid Arthritis in Greece

Rheumatoid Arthritis Clinical Trial

— HORA  

Official title:

Rheumatoid Arthritis in Greece: The Economic Burden of the Disease and the Impact on Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001182
• Other study ID #: 0881A1-102329
• Secondary ID: B1801120
• Status: Completed
• Phase: N/A
• First received: October 23, 2009
• Last updated: July 25, 2014
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: July 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• non interventional
non interventional

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

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

External Links

•   To obtain contact information for a study center near you, click here.