An observational study in Rheumatoid Arthritis, sponsored by Abbott. Completed at 10 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-11.
Sponsored by Abbott · Observational
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:
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.
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
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 124 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.
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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
Exclusion Criteria:
Eligible rheumatoid arthritis patients treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 12 months
| Milestone | Adalimumab Treatment |
|---|---|
| Started | 124 |
| Completed | 76 |
| Not completed | 48 |
| Withdrew: Lost to follow-up | 17 |
| Withdrew: Adverse event | 5 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Lack of effectiveness | 15 |
| Withdrew: Case report form not completed | 3 |
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.
| Euros | Adalimumab Treatment |
|---|---|
| Direct Costs at Baseline (n=121) | 272.99 ± 383.48 |
| Indirect Costs at Baseline (n=13) | 1162.62 ± 1146.60 |
| Direct Costs at 3 months (n=104) | 2662.73 ± 446.86 |
| Indirect Costs at 3 months (n=8) | 659.13 ± 648.82 |
| Direct Costs at 6 months (n=91) | 2692.28 ± 243.82 |
| Indirect Costs at 6 months (n=4) | 500.00 ± 336.65 |
| Direct Costs at 12 months (n=76) | 2649.42 ± 533.47 |
| Indirect Costs at 12 months (n=1) | 580.00 ± 0 |
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.
| Units on a scale | Adalimumab Treatment |
|---|---|
| EQ-5D Score at Baseline | 0.43 ± 0.16 |
| EQ-5D Score at 3 months | 0.53 ± 0.23 |
| EQ-5D Score at 6 months | 0.56 ± 0.23 |
| ED-5D Score at 12 months | 0.62 ± 0.25 |
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.
| units on a scale | Adalimumab Treatment |
|---|---|
| HAQ Score at Baseline | 1.33 ± 0.70 |
| HAQ Score at 3 months | 0.95 ± 0.80 |
| HAQ Score at 6 months | 0.83 ± 0.64 |
| HAQ Score at 12 months | 0.62 ± 0.64 |
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).
| Units on a scale | Adalimumab Treatment |
|---|---|
| Physical Functioning Score at Baseline | 33.5 ± 26.0 |
| Physical Functioning Score at 3 months | 50.0 ± 29.4 |
| Physical Functioning Score at 6 months | 56.4 ± 27.8 |
| Physical Functioning Score at 12 months | 60.0 ± 28.9 |
| Role Physical Score at Baseline | 18.7 ± 34.0 |
| Role Physical Score at 3 months | 36.8 ± 43.3 |
| Role Physical Score at 6 months | 41.0 ± 43.7 |
| Role Physical Score at 12 months | 51.0 ± 45.0 |
| Bodily Pain Score at Baseline | 37.2 ± 20.6 |
| Bodily Pain Score at 3 months | 55.5 ± 23.5 |
| Bodily Pain Score at 6 months | 60.0 ± 24.5 |
| Bodily Pain Score at 12 months | 63.2 ± 23.1 |
| General Health Score at Baseline | 33.8 ± 20.5 |
| General Health Score at 3 months | 45.4 ± 23.5 |
| General Health Score at 6 months | 48.5 ± 23.5 |
| General Health Score at 12 months | 52.8 ± 23.1 |
| Vitality Score at Baseline | 35.8 ± 20.2 |
| Vitality Score at 3 months | 48.7 ± 21.0 |
| Vitality Score at 6 months | 51.0 ± 19.6 |
| Vitality Score at 12 months | 56.2 ± 18.4 |
| Social Functioning Score at Baseline | 47.4 ± 33.5 |
| Social Functioning Score at 3 months | 61.5 ± 28.5 |
| Social Functioning Score at 6 months | 63.7 ± 29.5 |
| Social Functioning Score at 12 months | 70.5 ± 26.3 |
| Role Emotional Score at Baseline | 32.0 ± 44.0 |
| Role Emotional Score at 3 months | 50.7 ± 47.4 |
| Role Emotional Score at 6 months | 54.6 ± 47.5 |
| Role Emotional Score at 12 months | 70.2 ± 42.1 |
| Mental Health Score at Baseline | 48.0 ± 21.0 |
| Mental Health Score at 3 months | 57.1 ± 20.0 |
| Mental Health Score at 6 months | 58.5 ± 20.0 |
| Mental Health Score at 12 months | 61.4 ± 16.8 |
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).
| Euros | Adalimumab Treatment |
|---|---|
| Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER) | 13,628 |
Collected over Adverse event data were not collected in this study with the exception of adverse events leading to withdrawal. Adverse events are collected in the main study NCT 01086033 (GREC-2004-06) and will be reported upon completion of that study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adalimumab Treatment | — | 3/124 (2.4%) | 2/124 (1.6%) |
| Event | Adalimumab Treatment |
|---|---|
| Acute Myocardial Infarction/Coronary Artery Bypass GraftCardiac disorders | 1/124 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 1/124 |
| CellulitisSkin and subcutaneous tissue disorders | 1/124 |
| Event | Adalimumab Treatment |
|---|---|
| Rash muculo-papularSkin and subcutaneous tissue disorders | 1/124 |
| HypersensitivityImmune system disorders | 1/124 |
| Age Continuous(years) | Adalimumab Treatment |
|---|---|
| Mean | 56.2 ± 12.9 |
| Sex: Female, Male(Participants) | Adalimumab Treatment |
|---|---|
| Female | 100 |
| Male | 21 |
| Region of Enrollment(participants) | Adalimumab Treatment |
|---|---|
| Greece | 121 |
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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