Rheumatoid Arthritis, Reumatoïde Artritis, cost-effectiveness, kosteneffectiviteit, doelmatigheid, daily clinical practice, dagelijkse klinische praktijk, biologicals, biologics, Targeted Immune Modulators, Rituximab, Abatacept, Adalimumab, Etanercept, Infliximab.
Conditions
Interventions
After having signed an informed consent form, patients will be randomly assigned to either rituximab, abatacept or second TNF alpha blocking therapy. Further treatment decisions are at the rheumatolog
Sponsors
Department of Rheumatology, University Medical Centre Sint Radboud
Eligibility
Inclusion criteria
Inclusion criteria: 1. RA diagnosis according to ACR criteria; 2. Having been treated adequately with one of the anti-TNF alpha agents with insufficient effects; 3. A moderate to high disease activity (DAS28 > 3.2).
Exclusion criteria
Exclusion criteria: 1. Former treatment with abatacept or rituximab; 2. Patient's or physician's preference for one of the agents; 3. Contraindications for the use of one of the agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary clinical outcome is the mean of the DAS28 score measured at 6, 9 and 12 months follow-up. Furthermore costs (measured from a societal perspective), and quality adjusted life years (measured using utilities generated by the Euroqol 5D), over the first 12 months are additional primary outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the health assessment questionnaire, the short-form 36, time to failure and the percentage of patients crossing over to another treatment. | — |
Contacts
Public ContactW. Kievit
Department of Rheumatology (470) Radboud University Nijmegen Medical Centre PObox 9101
Outcome results
None listed