Health Outcomes in Rheumatoid Arthritis in Greece


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Study Location
Pfizer Investigational Site
Herakleion, Crete, 70013, Greece


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Simultaneous participation in an interventional clinical trial.


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Advanced Information
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Rheumatoid Arthritis
Intervention Other: non interventional
non interventional
Study Groups/Cohorts Non interventional
Patients with RA diagnosis receiving any treatment for RA (DMARDS or biologics)
Intervention: Other: non interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 23, 2009)
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
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.
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
Administrative Information
NCT Number NCT01001182
Other Study ID Numbers 0881A1-102329
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Study Director:Pfizer Call CenterPfizer
PRS Account Pfizer
Verification Date July 2014