N/A
Completed N=124
Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT01078116 ↗Enrolled (actual)
124
Serious AEs
2.4%
Results posted
Jul 2011
Primary outcomePrimary: Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment — 272.99; 1162.62; 2662.73; 659.13 Euros
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment |
272.99; 1162.62; 2662.73; 659.13; 2692.28; 500.00 | — |
| PRIMARY Health Related Quality of Life (European Quality of Life 5 Dimensions) |
0.43; 0.53; 0.56; 0.62 | — |
| PRIMARY Health Related Quality of Life (Health Assessment Questionnaire) |
1.33; 0.95; 0.83; 0.62 | — |
| PRIMARY Health Related Quality of Life (Medical Outcome Study Short Form 36) |
33.5; 50.0; 56.4; 60.0; 18.7; 36.8 | — |
| PRIMARY Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER) |
13,628 | — |
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
Data sourced from ClinicalTrials.gov (NCT01078116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.