Rheumatoid arthritis
Conditions
Interventions
Patients are randomly assigned to dose reduction aiming a drug level of
respectively 2 mg/L or 5 mg/L
Sponsors
Reade
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: Rheumatoid arthritis patient, according to ACR 1987/2010 criteria; Treated for at least 28 weeks with adalimumab Adalimumab trough concentration >5mg/L Who has agreed to participate (written informed consent); Age 16 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; No other disease that might flare if adalimumab is tapered like psoriasis, inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is the difference in mean time weighted DAS28-CRP between week 0 and 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in mean time weighted DAS28-CRP between study groups after 12 weeks Direct medical costs (medication, non-scheduled visits due flares, cost TDM testing) over 24 weeks Agreement between algorithm predicted and measured adalimumab concentrations at week 24. Number of flares and dose-interval shortenings after 24 weeks. | — |
Countries
Netherlands
Outcome results
None listed