chronic arthritis rheumatoid arthritis
Conditions
Interventions
In the intervention group usual care and tight control is provided and the
treating rheumatologist is advised to try to increase interval of adalimumab or
etanercept.
If a patient uses adalimumab th
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Rheumatoid arthritis (either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion) - Using either adalimumab or etanercept (all dose/interval regimens, all background medication including DMARDs and corticosteroids up to 5 mg, higher doses of steroids should be reduced first) - 6 months of stable low disease activity while using adalimumab or etanercept (operationalised by either a DAS28
Exclusion criteria
Exclusion criteria: - Co morbidity that also requires treatment with anti-TNF and thus prevents dose reduction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Cumulative incidence of patients fulfilling prespecified loss of response/flare criteria in the intervention and the usual care group after 9 months and after 18 months of follow up. - Cost effectiveness (cost minimisation) ratio between intervention group and usual care group for the 9 month induction phase and for the 12 months maintenance phase. - Predictive values/characteristics of a prediction model including (change in) serum drug levels and PET arthritis. - Proportion of patients with a change in modified Sharp-van der Heijde Score> MCIC in the intervention and usual care group. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mean DAS28 in intervention and usual care group at 9 and 18 months follow up. - Mean time averaged DAS28 in intervention and usual care group at 9 and 18 months follow up. - Proportion of patients with a DAS28 | — |
Countries
Netherlands
Outcome results
None listed