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Health Outcomes in Rheumatoid Arthritis in Greece (HORA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01001182
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : July 28, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: non interventional

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.

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rheumatoid Arthritis in Greece: The Economic Burden of the Disease and the Impact on Quality of Life
Study Start Date : July 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Non interventional
Patients with RA diagnosis receiving any treatment for RA (DMARDS or biologics)
Other: non interventional
non interventional

Primary Outcome Measures :
  1. Quality of life [ Time Frame: 1 year ]
  2. Resource utilization [ Time Frame: 1 year ]
  3. Productivity losses [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Functional ability [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01001182

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Pfizer Investigational Site
Herakleion, Crete, Greece, 70013
Pfizer Investigational Site
Mezourlo, Larissa, Greece, 41500
Pfizer Investigational Site
Rio, Patras, Greece, 26500
Pfizer Investigational Site
Alexandroupoli, Greece, 68100
Pfizer Investigational Site
Athens, Greece, 11527
Pfizer Investigational Site
Ioannina, Greece, 45332
Pfizer Investigational Site
Thessaloniki, Greece, 54636
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT01001182    
Other Study ID Numbers: 0881A1-102329
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014
Keywords provided by Pfizer:
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases