Rheumatoid Arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with RA (2010 ARA criteria or clinical judgment by a rheumatologist) Initiating a new (subcutaneously administered) bDMARD >18 years Sufficient ability to understand Dutch Be able to be followed for 12 months (life expectancy)
Exclusion criteria
Exclusion criteria: Large cognitive limitations Assistance in taking drugs (e.g. home care) Included in another randomised controlled trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the difference in proportion of non-adherence patients (less than 80% medication adherence) after 1 year between the intervention group and in the usual care control group assessed with the validated compliance questionnaire on rheumatology (CQR) and pharmacy refill data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be time to low disease activity and remission, serum trough levels (optional) and proportion of switching patients to another biological and mean disease activity after 1 year. Finally an economic evaluation of the possible added value of electronic drug monitor feedback compared with usual care will be done. | — |
Countries
Netherlands