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Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis (RA)

NCT01078116 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 124

Last updated 2011-08-11

Study results available
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Summary

Evaluation of Health Related Quality of Life (HRQL) is of a paramount importance in assessing the impact of rheumatoid arthritis on patients' health status, however when costs associated with rheumatoid arthritis are also taken into account, the information provided may lead to a more balanced view in analyzing the treatment of the disease.

In accordance with the above, the main objective this study was to evaluate the impact of adalimumab treatment not only on patients' Health Related Quality of Life but also on the cost of the disease management. In order to accomplish this the study has been focused on:

1. Estimating the direct and indirect cost incurred by adalimumab treatment.
2. Measuring the Health Related Quality of Life of rheumatoid arthritis patients under adalimumab treatment.
3. Exploring the cost-utility relationship of rheumatoid arthritis patients treated with adalimumab by combining the Health Related Quality of Life of rheumatoid arthritis patients and direct as well as indirect costs due to RA.

More specifically, data related to patients' Health Related Quality of Life and cost associated with rheumatoid arthritis will be recorded for one-year period, and collected at four subsequent visits: baseline, month 3, 6 and 12. The visit before starting treatment with adalimumab will be considered as baseline. This information was used to compare Health Related Quality of Life and cost data before and after adalimumab initiation and therefore identify the effect of adalimumab treatment in patients with rheumatoid arthritis.

Conditions

Sponsors & Collaborators

  • Institute of Political Economical & Social Researches, Greece

    collaborator UNKNOWN

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Thanasis Floros, MD · Abbott Laboratories Hellas S.A.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Greece

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01078116 on ClinicalTrials.gov