Health Outcomes in Rheumatoid Arthritis in Greece

NCT01001182 | Completed

• 2 other identifiers: 0881A1-102329B1801120
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 7

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.

Conditions

Rheumatoid Arthritis

Keywords

observational; non-interventional; prospective

Outcome Measures

Primary Outcomes (3)

• Quality of life

  1 year

• Resource utilization

  1 year

• Productivity losses

  1 year

Secondary Outcomes (1)

• Functional ability

  1 year

Study Arms (1)

Non interventional

Patients with RA diagnosis receiving any treatment for RA (DMARDS or biologics)

Other: non interventional

Interventions

non interventional OTHER

non interventional

Non interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Simultaneous participation in an interventional clinical trial.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Pfizer Investigational Site

Alexandroupoli, Alexandroupoli, 68100, Greece

Location

Pfizer Investigational Site

Athens, Athens, 11527, Greece

Location

Pfizer Investigational Site

Heraklion, Crete, 70013, Greece

Location

Pfizer Investigational Site

Ioannina, Ioannina, 45332, Greece

Location

Pfizer Investigational Site

Mezourlo, Larissa, 41500, Greece

Location

Pfizer Investigational Site

Rio, Patras, 26500, Greece

Location

Pfizer Investigational Site

Thessaloniki, Thessaloniki, 54636, Greece

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 26, 2009
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

GR (7)