Health Outcomes in Rheumatoid Arthritis in Greece (HORA)

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Greece
  • Alexandroupoli, Greece, 68100
    • Pfizer Investigational Site
  • Athens, Greece, 11527
    • Pfizer Investigational Site
  • Ioannina, Greece, 45332
    • Pfizer Investigational Site
  • Thessaloniki, Greece, 54636
    • Pfizer Investigational Site
  • Crete
    • Herakleion, Crete, Greece, 70013
      • Pfizer Investigational Site
  • Larissa
    • Mezourlo, Larissa, Greece, 41500
      • Pfizer Investigational Site
  • Patras
    • Rio, Patras, Greece, 26500
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of life	1 year
Resource utilization	1 year
Productivity losses	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional ability	1 year

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: October 23, 2009
• First Submitted That Met QC Criteria: October 23, 2009
• First Posted (Estimate): October 26, 2009

Study Record Updates

• Last Update Posted (Estimate): July 28, 2014
• Last Update Submitted That Met QC Criteria: July 25, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: prospective; observational; non-interventional
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 0881A1-102329; B1801120