Rheumatoid Arthritis
Conditions
Interventions
Patients will be randomized (1:1) to a treatment strategy starting with tsDMARD or a treatment strategy starting with TNFi. Patients will be followed up over the course of 48 weeks with scheduled clin
Sponsors
prof. dr. M.A.F.J. van de Laar
Eligibility
Inclusion criteria
Inclusion criteria: Clinical diagnosis of RA Active disease (for example DAS28> 3.2 ) Former treatment according to T2T principles, at the discretion of the attending rheumatologist, i.e. past treatment decisions informed by disease activity measurements Previous use of at least one csDMARD
Exclusion criteria
Exclusion criteria: Disease duration >5 years Previous treatment with any biological DMARD or tsDMARD Contraindication for either TNFi or baricitinib Latent or active tuberculosis Active or recurrent infections 3x upper limit of normal ALAT GFR < 30 ml/min. Failure to provide written informed consent Refusal to use effective contraceptive during the study period
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include ACR20, 50, and 70 across measurement points, the percentage of patients achieving sustained SDAI remission, time to first SDAI remission, radiographic progression, health economics, safety, and change from baseline in DAS28 score and patient-reported outcomes (PROMs). | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is non-inferiority of tsDAMRD first versus TNFi first in terms of ACR50 response at 12 weeks | — |
Contacts
Public ContactDanyta Tedjo
Transparency in Healthcare
Outcome results
None listed