Clinical trial NCT01078116: Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis (RA)
Official title: Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Adalimumab treatment
Evaluation of the patients' Health Related Quality of Life
Cost of the disease management
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Institute of Political Economical & Social Researches, Greece
First posted: 2010-03-02
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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. 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.

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 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

Primary outcomes:
measure: Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
timeFrame: Enrollment visit (Baseline), month 3, month 6, month 12
measure: Health Related Quality of Life (European Quality of Life 5 Dimensions)
timeFrame: Enrollment visit (Baseline), month 3, month 6, month 12
measure: Health Related Quality of Life (Health Assessment Questionnaire)
timeFrame: Enrollment visit (Baseline), month 3, month 6, month 12
measure: Health Related Quality of Life (Medical Outcome Study Short Form 36)
timeFrame: Enrollment visit (Baseline), month 3, month 6, month 12
measure: Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 32052
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 32068
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 32069
city: Crete
country: Greece
facility: Site Reference ID/Investigator# 32071
city: Ioannina
country: Greece
facility: Site Reference ID/Investigator# 32072
city: Larissa
country: Greece
facility: Site Reference ID/Investigator# 32073
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 32064
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 32065
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 32066
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 32067
Study officials:
affiliation: Abbott Laboratories Hellas S.A.
name: Thanasis Floros, MD
role: STUDY_CHAIR
References: