Trial Outcomes & Findings for Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis (RA) (NCT NCT01078116)
NCT ID: NCT01078116
Last Updated: 2011-08-11
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
124 participants
Primary outcome timeframe
Enrollment visit (Baseline), month 3, month 6, month 12
Results posted on
2011-08-11
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
124
|
|
Overall Study
COMPLETED
|
76
|
|
Overall Study
NOT COMPLETED
|
48
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Lack of effectiveness
|
15
|
|
Overall Study
Case report form not completed
|
3
|
Baseline Characteristics
Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Adalimumab Treatment
n=121 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
|
|---|---|
|
Age Continuous
|
56.2 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
121 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment visit (Baseline), month 3, month 6, month 12Population: Analysis is based on the number of participants completing the assessments at each visit.
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.
Outcome measures
| Measure |
Adalimumab Treatment
n=121 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
|
|---|---|
|
Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Direct Costs at Baseline (n=121)
|
272.99 Euros
Standard Deviation 383.48
|
|
Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Indirect Costs at Baseline (n=13)
|
1162.62 Euros
Standard Deviation 1146.60
|
|
Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Direct Costs at 3 months (n=104)
|
2662.73 Euros
Standard Deviation 446.86
|
|
Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Indirect Costs at 3 months (n=8)
|
659.13 Euros
Standard Deviation 648.82
|
|
Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Direct Costs at 6 months (n=91)
|
2692.28 Euros
Standard Deviation 243.82
|
|
Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Indirect Costs at 6 months (n=4)
|
500.00 Euros
Standard Deviation 336.65
|
|
Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Direct Costs at 12 months (n=76)
|
2649.42 Euros
Standard Deviation 533.47
|
|
Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Indirect Costs at 12 months (n=1)
|
580.00 Euros
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Enrollment visit (Baseline), month 3, month 6, month 12Population: Analysis is based on the number of participants completing the assessments at each visit.
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.
Outcome measures
| Measure |
Adalimumab Treatment
n=121 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
|
|---|---|
|
Health Related Quality of Life (European Quality of Life 5 Dimensions)
EQ-5D Score at Baseline
|
0.43 Units on a scale
Standard Deviation 0.16
|
|
Health Related Quality of Life (European Quality of Life 5 Dimensions)
EQ-5D Score at 3 months
|
0.53 Units on a scale
Standard Deviation 0.23
|
|
Health Related Quality of Life (European Quality of Life 5 Dimensions)
EQ-5D Score at 6 months
|
0.56 Units on a scale
Standard Deviation 0.23
|
|
Health Related Quality of Life (European Quality of Life 5 Dimensions)
ED-5D Score at 12 months
|
0.62 Units on a scale
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: Enrollment visit (Baseline), month 3, month 6, month 12Population: Analysis is based on the number of participants completing the assessment at each time point.
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.
Outcome measures
| Measure |
Adalimumab Treatment
n=121 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
|
|---|---|
|
Health Related Quality of Life (Health Assessment Questionnaire)
HAQ Score at Baseline
|
1.33 units on a scale
Standard Deviation 0.70
|
|
Health Related Quality of Life (Health Assessment Questionnaire)
HAQ Score at 3 months
|
0.95 units on a scale
Standard Deviation 0.80
|
|
Health Related Quality of Life (Health Assessment Questionnaire)
HAQ Score at 6 months
|
0.83 units on a scale
Standard Deviation 0.64
|
|
Health Related Quality of Life (Health Assessment Questionnaire)
HAQ Score at 12 months
|
0.62 units on a scale
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: Enrollment visit (Baseline), month 3, month 6, month 12Population: Analysis is based on the number of participants completing the assessment at each time point.
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).
Outcome measures
| Measure |
Adalimumab Treatment
n=121 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
|
|---|---|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Physical Functioning Score at Baseline
|
33.5 Units on a scale
Standard Deviation 26.0
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Physical Functioning Score at 3 months
|
50.0 Units on a scale
Standard Deviation 29.4
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Physical Functioning Score at 6 months
|
56.4 Units on a scale
Standard Deviation 27.8
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Physical Functioning Score at 12 months
|
60.0 Units on a scale
Standard Deviation 28.9
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Role Physical Score at Baseline
|
18.7 Units on a scale
Standard Deviation 34.0
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Role Physical Score at 3 months
|
36.8 Units on a scale
Standard Deviation 43.3
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Role Physical Score at 6 months
|
41.0 Units on a scale
Standard Deviation 43.7
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Role Physical Score at 12 months
|
51.0 Units on a scale
Standard Deviation 45.0
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Bodily Pain Score at Baseline
|
37.2 Units on a scale
Standard Deviation 20.6
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Bodily Pain Score at 3 months
|
55.5 Units on a scale
Standard Deviation 23.5
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Bodily Pain Score at 6 months
|
60.0 Units on a scale
Standard Deviation 24.5
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Bodily Pain Score at 12 months
|
63.2 Units on a scale
Standard Deviation 23.1
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
General Health Score at Baseline
|
33.8 Units on a scale
Standard Deviation 20.5
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
General Health Score at 3 months
|
45.4 Units on a scale
Standard Deviation 23.5
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
General Health Score at 6 months
|
48.5 Units on a scale
Standard Deviation 23.5
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
General Health Score at 12 months
|
52.8 Units on a scale
Standard Deviation 23.1
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Vitality Score at Baseline
|
35.8 Units on a scale
Standard Deviation 20.2
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Vitality Score at 3 months
|
48.7 Units on a scale
Standard Deviation 21.0
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Vitality Score at 6 months
|
51.0 Units on a scale
Standard Deviation 19.6
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Vitality Score at 12 months
|
56.2 Units on a scale
Standard Deviation 18.4
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Social Functioning Score at Baseline
|
47.4 Units on a scale
Standard Deviation 33.5
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Social Functioning Score at 3 months
|
61.5 Units on a scale
Standard Deviation 28.5
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Social Functioning Score at 6 months
|
63.7 Units on a scale
Standard Deviation 29.5
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Social Functioning Score at 12 months
|
70.5 Units on a scale
Standard Deviation 26.3
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Role Emotional Score at Baseline
|
32.0 Units on a scale
Standard Deviation 44.0
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Role Emotional Score at 3 months
|
50.7 Units on a scale
Standard Deviation 47.4
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Role Emotional Score at 6 months
|
54.6 Units on a scale
Standard Deviation 47.5
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Role Emotional Score at 12 months
|
70.2 Units on a scale
Standard Deviation 42.1
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Mental Health Score at Baseline
|
48.0 Units on a scale
Standard Deviation 21.0
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Mental Health Score at 3 months
|
57.1 Units on a scale
Standard Deviation 20.0
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Mental Health Score at 6 months
|
58.5 Units on a scale
Standard Deviation 20.0
|
|
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Mental Health Score at 12 months
|
61.4 Units on a scale
Standard Deviation 16.8
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Cost-utility analysis is based on the 76 participants who completed the study through 12 months.
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).
Outcome measures
| Measure |
Adalimumab Treatment
n=76 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
|
|---|---|
|
Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER)
|
13,628 Euros
|
Adverse Events
Adalimumab Treatment
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab Treatment
n=124 participants at risk
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
|
|---|---|
|
Cardiac disorders
Acute Myocardial Infarction/Coronary Artery Bypass Graft
|
0.81%
1/124 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.81%
1/124 • 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.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.81%
1/124 • 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.
|
Other adverse events
| Measure |
Adalimumab Treatment
n=124 participants at risk
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
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash muculo-papular
|
0.81%
1/124 • 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.
|
|
Immune system disorders
Hypersensitivity
|
0.81%
1/124 • 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.
|
Additional Information
Global Medical Services
Abbott
Phone: 1-800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER