Health Outcomes in Rheumatoid Arthritis in Greece

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: non interventional

• Registration Number: NCT01001182
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Study Start: 2010-07
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non interventional	non interventional	Patients with RA diagnosis receiving any treatment for RA (DMARDS or biologics)

Primary Outcome Measures

Name	Time	Method
Quality of life	1 year
Resource utilization	1 year
Productivity losses	1 year

Secondary Outcome Measures

Name	Time	Method
Functional ability	1 year

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇷 Thessaloniki, Greece