Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institute of Political Economical & Social Researches, Greece | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Rheumatoid Arthritis | Eligible rheumatoid arthritis patients treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thanasis Floros, MD | Abbott Laboratories Hellas S.A. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 32052 | Athens | 115 21 | Greece | |||
| Site Reference ID/Investigator# 32068 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab Treatment | Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab Treatment | Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Based on population of 121 participants analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis is based on the number of participants completing the assessments at each visit. | Posted | Mean | Standard Deviation | Euros | Enrollment visit (Baseline), month 3, month 6, month 12 |
|
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.
Only adverse events leading to withdrawal are recorded. Adverse events are collected in the main study NCT 01086033 (GREC-2004-06) and will be reported upon completion of that study. Number of participants at risk (N=124) and adverse event frequency threshold refers only to withdrawals due to adverse event, not overall adverse event reporting.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adalimumab Treatment | Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction/Coronary Artery Bypass Graft | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment | Serious adverse event leading to study withdrawal for one participant. Number of participants at risk (N=124) refers only to study withdrawals due to adverse event, not overall adverse event reporting. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash muculo-papular | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Nonserious adverse event leading to study withdrawal for one participant.Number of participants at risk (N=124) and adverse event reporting frequency threshold refer only to study withdrawals due to adverse event, not overall adverse event reporting. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Athens |
| 115 27 |
| Greece |
| Site Reference ID/Investigator# 32069 | Athens | 11527 | Greece |
| Site Reference ID/Investigator# 32071 | Crete | 71500 | Greece |
| Site Reference ID/Investigator# 32072 | Ioannina | 45500 | Greece |
| Site Reference ID/Investigator# 32073 | Larissa | 41221 | Greece |
| Site Reference ID/Investigator# 32064 | Thessaloniki | 54636 | Greece |
| Site Reference ID/Investigator# 32065 | Thessaloniki | 54642 | Greece |
| Site Reference ID/Investigator# 32066 | Thessaloniki | 564 29 | Greece |
| Site Reference ID/Investigator# 32067 | Thessaloniki | 570 10 | Greece |
| Lack of effectiveness |
|
| Case report form not completed |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Based on population of 121 participants analyzed. | Count of Participants | Participants |
|
| Region of Enrollment | Based on population of 121 participants analyzed. | Number | participants |
|
Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
|
|
| Primary | 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. | Analysis is based on the number of participants completing the assessments at each visit. | Posted | Mean | Standard Deviation | Units on a scale | Enrollment visit (Baseline), month 3, month 6, month 12 |
|
|
|
| Primary | 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. | Analysis is based on the number of participants completing the assessment at each time point. | Posted | Mean | Standard Deviation | units on a scale | Enrollment visit (Baseline), month 3, month 6, month 12 |
|
|
|
| Primary | 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). | Analysis is based on the number of participants completing the assessment at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Enrollment visit (Baseline), month 3, month 6, month 12 |
|
|
|
| Primary | 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). | Cost-utility analysis is based on the 76 participants who completed the study through 12 months. | Posted | Number | Euros | 12 months |
|
|
|
| 3 |
| 124 |
| 2 |
| 124 |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Serious adverse event leading to study withdrawal for one participant. Number of participants at risk (N=124) refers only to study withdrawals due to adverse event, not overall adverse event reporting. |
|
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Serious adverse event leading to study withdrawal for one participant. Number of participants at risk (N=124) refers only to study withdrawals due to adverse events, not overall adverse event reporting. |
|
|
| Hypersensitivity | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment | Nonserious adverse event leading to study withdrawal in one participant. Number of participants at risk (N=124) and adverse event reporting frequency threshold refer only to study withdrawals due to adverse event, not overall adverse event reporting. |
|
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| ED-5D Score at 12 months |
|
| Title | Measurements |
|---|---|
|
| HAQ Score at 12 months |
|
|
| Physical Functioning Score at 12 months |
|
| Role Physical Score at Baseline |
|
| Role Physical Score at 3 months |
|
| Role Physical Score at 6 months |
|
| Role Physical Score at 12 months |
|
| Bodily Pain Score at Baseline |
|
| Bodily Pain Score at 3 months |
|
| Bodily Pain Score at 6 months |
|
| Bodily Pain Score at 12 months |
|
| General Health Score at Baseline |
|
| General Health Score at 3 months |
|
| General Health Score at 6 months |
|
| General Health Score at 12 months |
|
| Vitality Score at Baseline |
|
| Vitality Score at 3 months |
|
| Vitality Score at 6 months |
|
| Vitality Score at 12 months |
|
| Social Functioning Score at Baseline |
|
| Social Functioning Score at 3 months |
|
| Social Functioning Score at 6 months |
|
| Social Functioning Score at 12 months |
|
| Role Emotional Score at Baseline |
|
| Role Emotional Score at 3 months |
|
| Role Emotional Score at 6 months |
|
| Role Emotional Score at 12 months |
|
| Mental Health Score at Baseline |
|
| Mental Health Score at 3 months |
|
| Mental Health Score at 6 months |
|
| Mental Health Score at 12 months |
|