rheumatoid arthritis
Conditions
Interventions
- Drug concentration guided group: Dose-interval will be prolonged using
adalimumab serum concentration at week 16,
- Disease activity-guided group: dose interval is prolonged using disease
activit
Sponsors
Jan van Breemen Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Rheumatoid arthritis patient, according to ACR 1987 /2010 criteria; Starting adalimumab as the first biological therapy Written informed consent Age 18 years or older.
Exclusion criteria
Exclusion criteria: Scheduled surgery during the follow-up of the study or other pre-planned reasons for treatment discontinuation; Life expectancy shorter than follow-up period of the study; Other disease that might flare if adalimumab is tapered like psoriasis, inflammatory bowel disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main parameter used to investigate the primary objective is direct medical costs associated with adalimumab dose reduction strategies (medication, non-scheduled visits due flares, cost TDM testing) over 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in mean time weighted DAS28-CRP between study groups at 16, 28, 52 and 80 weeks. Direct medical costs (medication, visits, cost TDM testing) of both study groups after 28, 40 and 80 weeks. Indirect medical costs of both study group at 52 and 80 weeks of treatment. Percentage of patients with DAS28-CRP | — |
Countries
Netherlands
Outcome results
None listed