Baricitinib bij patiënten met reumatoïde artritis
Recruiting
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NL-OMON20976
- Lead Sponsor
- prof. dr. M.A.F.J. van de Laar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is non-inferiority of tsDAMRD first versus TNFi first in terms of ACR50 response at 12 weeks
- Secondary Outcome Measures
Name Time Method 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).