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

NCT01078116 | Completed Results

• 1 other identifier: P10-159
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 10

Brief 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. 1.Estimating the direct and indirect cost incurred by adalimumab treatment.
2. 2.Measuring the Health Related Quality of Life of rheumatoid arthritis patients under adalimumab treatment.
3. 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Adalimumab treatment; Evaluation of the patients' Health Related Quality of Life; Cost of the disease management

Outcome Measures

Primary Outcomes (5)

• Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment

  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.

  Enrollment visit (Baseline), month 3, month 6, month 12

• Health Related Quality of Life (European Quality of Life 5 Dimensions)

  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.

  Enrollment visit (Baseline), month 3, month 6, month 12

• Health Related Quality of Life (Health Assessment Questionnaire)

  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.

  Enrollment visit (Baseline), month 3, month 6, month 12

• Health Related Quality of Life (Medical Outcome Study Short Form 36)

  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).

  Enrollment visit (Baseline), month 3, month 6, month 12

• Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER)

  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).

  12 months

Study Arms (1)

Patients with Rheumatoid Arthritis

Eligible rheumatoid arthritis patients treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union

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 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Abbott: lead
• Institute of Political Economical & Social Researches, Greece: collaborator

Study Sites (10)

Site Reference ID/Investigator# 32052

Athens, 115 21, Greece

Location

Site Reference ID/Investigator# 32068

Athens, 115 27, Greece

Location

Site Reference ID/Investigator# 32069

Athens, 11527, Greece

Location

Site Reference ID/Investigator# 32071

Crete, 71500, Greece

Location

Site Reference ID/Investigator# 32072

Ioannina, 45500, Greece

Location

Site Reference ID/Investigator# 32073

Larissa, 41221, Greece

Location

Site Reference ID/Investigator# 32064

Thessaloniki, 54636, Greece

Location

Site Reference ID/Investigator# 32065

Thessaloniki, 54642, Greece

Location

Site Reference ID/Investigator# 32066

Thessaloniki, 564 29, Greece

Location

Site Reference ID/Investigator# 32067

Thessaloniki, 570 10, Greece

Location

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

Limitations and Caveats

Study NCT 01078116 (P10-159) is a substudy of NCT 01086033(GREC-2004-06). Adverse events were not recorded in this study but will be reported in the main study upon completion. Only adverse events leading to withdrawal are reported in this substudy.

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Thanasis Floros, MD

  Abbott Laboratories Hellas S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 2, 2010
• Study Start: November 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 11, 2011
• Results First Posted: July 25, 2011

Record last verified: 2011-08

Locations

GR (10)