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

This study has been completed.
Sponsor:
Collaborator:
Institute of Political Economical & Social Researches, Greece
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01078116
First received: February 26, 2010
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment [ Time Frame: Enrollment visit (Baseline), month 3, month 6, month 12 ] [ Designated as safety issue: No ]
    Direct and indirect per-participant costs were estimated at Baseline (enrollment visit) for the 3-month period prior to initiation of adalimumab treatment, and at 3, 6 and 12 months following initiation of treatment. Direct costs included pharmaceutical costs, diagnostic and monitoring test costs, hospitalization costs, rheumatologist's costs, social insurance rheumatologist's costs, other specialists costs, physiotherapy costs, rehabilitation cost, home care cost, equipment cost and transportation cost. Indirect costs refer to loss of income due to rheumatoid arthritis disability.

  • Health Related Quality of Life (European Quality of Life 5 Dimensions) [ Time Frame: Enrollment visit (Baseline), month 3, month 6, month 12 ] [ Designated as safety issue: No ]
    European Quality of Life 5 Dimensions (EQ-5D) is a generic health related quality of life instrument which assesses 5 health dimensions on a scale of 1 (no problems) to 5 (worst health). An overall score is derived ranging from -.59 to +1; a higher score indicates better health.

  • Health Related Quality of Life (Health Assessment Questionnaire) [ Time Frame: Enrollment visit (Baseline), month 3, month 6, month 12 ] [ Designated as safety issue: No ]
    Health Assessment Questionnaire (HAQ) is designed to assess patients' abilities to perform activities of daily living. Scores range between 0 and 3, where higher values represent worse outcomes.

  • Health Related Quality of Life (Medical Outcome Study Short Form 36) [ Time Frame: Enrollment visit (Baseline), month 3, month 6, month 12 ] [ Designated as safety issue: No ]
    Medical Outcome Study Short Form 36 (MOS SF-36) is a generic health related quality of life assessment that consists of 36 questions within 8 domains. Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best).

  • Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The ICER calculation is based on comparison of differences in costs and utilities (based on Quality of Life Adjusted years [QALYs]) between Baseline and the 12 month visit. The ICER represents the extra costs that have to be incurred for one extra unit of perfect health to be produced. A treatment is determined to be cost-effective if the ICER is below a certain threshold (National Health Systems of European Union have suggested a threshold of 50,000 euros).


Enrollment: 124
Study Start Date: November 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Rheumatoid Arthritis
Eligible rheumatoid arthritis patients treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union

Detailed Description:

Data concerning patients' Health Related Quality of Life as well as the cost of the disease treatment were collected at four subsequent periods and specifically at baseline (Visit 1), and at months 3, 6 and 12.

Moreover, at baseline patients' socioeconomic, and history of illness data as well as the use of other prescribed medication and costs due to rheumatoid arthritis have been recorded, in order to identify patients' health state before adalimumab treatment initiation.

Patients discontinuing therapy (drop-outs) either due to adverse events or on their own initiative were categorized and analyzed separately, while reasons leading to discontinuation were recorded. Adverse events were not collected in this study with the exception of adverse events leading to withdrawal.

In order to evaluate the cost-utility of adalimumab both the cost of the disease treatment and the Health Related Quality of Life of rheumatoid arthritis patients have been taken into account. The process is described below:

Face-to-face interviews were conducted by the physicians/investigators in charge in all four subsequent periods as well as before adalimumab treatment initiation. A questionnaire, divided into the following sections, was administered: 1. Patients' Sociodemographic Characteristics 2. Measurement of Health Related Quality of Life in Rheumatoid Arthritis patients 3. Cost Assessment

  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 with rheumatoid arthritis, from hospital centres and private physicians, who were prescribed adalimimab according to the approved SmPC in the European Union, prior to the study enrollment

Criteria

Inclusion Criteria:

  • Patients with moderate or severe active rheumatoid arthritis, who have been prescribed and are receiving adalimumab under normal clinical practice for at least one month and according to the approved Summary of Product Characteristics (SmPC) in the European Union.
  • Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria:

  • Contraindications according to the SmPC
  • Patients should not participate in other observational Abbott study
  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: NCT01078116

Locations
Greece
Site Reference ID/Investigator# 32052
Athens, Greece, 115 21
Site Reference ID/Investigator# 32068
Athens, Greece, 115 27
Site Reference ID/Investigator# 32069
Athens, Greece, 11527
Site Reference ID/Investigator# 32071
Crete, Greece, 71500
Site Reference ID/Investigator# 32072
Ioannina, Greece, 45500
Site Reference ID/Investigator# 32073
Larissa, Greece, 41221
Site Reference ID/Investigator# 32064
Thessaloniki, Greece, 54636
Site Reference ID/Investigator# 32066
Thessaloniki, Greece, 564 29
Site Reference ID/Investigator# 32065
Thessaloniki, Greece, 54642
Site Reference ID/Investigator# 32067
Thessaloniki, Greece, 570 10
Sponsors and Collaborators
Abbott
Institute of Political Economical & Social Researches, Greece
Investigators
Study Chair: Thanasis Floros, MD Abbott Laboratories Hellas S.A.
  More Information

No publications provided

Responsible Party: Tina Antachopoulou / Medical Director, Abbott Laboratories Hellas S.A.
ClinicalTrials.gov Identifier: NCT01078116     History of Changes
Other Study ID Numbers: P10-159
Study First Received: February 26, 2010
Results First Received: June 24, 2011
Last Updated: August 9, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by Abbott:
Rheumatoid Arthritis
Adalimumab treatment
Evaluation of the patients' Health Related Quality of Life
Cost of the disease management

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014