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Health Outcomes in Rheumatoid Arthritis in Greece (HORA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01001182
First received: October 23, 2009
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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 Intervention
Rheumatoid Arthritis
Other: non interventional

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Resource utilization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Productivity losses [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional ability [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: July 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non interventional
Patients with RA diagnosis receiving any treatment for RA (DMARDS or biologics)
Other: non interventional
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001182

Locations
Greece
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01001182     History of Changes
Other Study ID Numbers: 0881A1-102329, B1801120
Study First Received: October 23, 2009
Last Updated: July 25, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Pfizer:
observational
non-interventional
prospective

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014