Rheumatoid Arthritis (RA)
Conditions
Interventions
Participating hospitals will receive the developed implementation strategy that aims to improve tight control and disease activity guided bDMARD dose optimization The strategy consists of the followin
Sponsors
This is an investigator-initiated study, funded by the Sint Maartenskliniek
Eligibility
Inclusion criteria
Inclusion criteria: • Rheumatoid arthritis (clinical diagnosis of treating rheumatologist, fulfilled at any time point between start of the disease and inclusion) operationalized by DOT diagnosis 101. • Being treated in a center in which the RAINBOW implementation project is starting • Females and males ≥18 years and mentally competent • Using a bDMARD (all dose/interval regimens, all background medication including sDMARDs and corticosteroids) • Informed consent given • Ability to measure the outcome of the study in this patient (e.g. life expectancy > 1,5 year, no planned relocation) • Ability to read and communicate well in Dutch
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •bDMARD use (amount prescribed by rheumatologist) •Disease activity (RAPID3 questionnaire) We want to investigate whether the extended implementation strategy is superior to the main strategy. This is the case if the following combined objective is met: the extended strategy reduces bDMARD use while being non-inferior on disease activity. Since testing for non-inferiority on disease activity is only relevant when the extended strategy proves to be effective in reducing bDMARD use, we will perform a fixed sequence testing procedure. First, we will test the difference between groups on bDMARD use. When the extended strategy has a significantly different effect on bDMARD use compared to the main strategy, we will continue to test for non-inferiority on disease activity. When the extended strategy does not have a significantly different effect on bDMARD use, we will not test disease activity. Thus we will first test H0= The addition of treatment advice to the main strategy (extended strategy) has the same effect on mean bDMARD use as the main strategy at 18 months. H1 = the addition of treatment advice to the main strategy (extended strategy) has a different effect than the main strategy on mean bDMARD use at 18 months. If this test is statistically significant, we will test: H0’= The addition of treatment advice is not non-inferior with regard to disease activity at 18 month. H1’= The addition of treatment advice is non-inferior with regard to disease activity at 18 months. The trial (and the extended implementation strategy) is considered a success if the first test shows that the extended program statistically significantly reduces bDMARD use compared to the main strategy and it is non-inferior on disease activity. However, due to the two-sided testing in the first test, we will also be able to conclude that the extended strategy statistically significantly increases bDMARD combined or not with non-inferiority on disease activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Quality of Life (EQ5D-5L) • bDMARD use (amount from declaration data) • bDMARD use (amount reported by patient) • Disease activity (DAS28/CDAI/SDAI) • Acute phase reactants (ESR, CRP) • Concomitant medication | — |
Contacts
Public ContactLise Verhoef
Sint Maartenskliniek, Research department, Hengstdal 3
Outcome results
None listed