Pragmatic trial baricitinib versus First biological in “Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT)

INTERVENTION: Trade Name: Olumiant Product Name: baricitinib Pharmaceutical Form: Film‐coated tablet CONDITION: Pragmatic trial baricitinib versus First biological in “Tight Controlâ€? Patients suffering from Rheumatoid Arthritis (PERFECT) Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: ; Secondary Objective: • To test for superiority of baricitinib first versus TNFi biological first in csDMARDs refractory RA patients in terms of ACR response, in case of noninferiority of baricitinib first.; • To evaluate safety of baricitinib versus biological (TNFi) first in csDMARDs refractory RA patients.; • To compare time to first remission and time to persistent remission between treatment arms.; • To compare radiographic outcomes between treatment arms.; • To compare patient reported outcomes between treatment arms.; • To perform a cost effectiveness analysis in which both treatment strategies are compared.; Main Objective: To demonstrate non‐inferiority of a T2T strategy in which conventional synthetic disease modifying drugs (csDMARDs) refractory RA patients are initially treated with tsDMARD baricitinib versus the comparable T2T strategy in which patients are initially treated with a biological tumor necrosis factor inhibitor (TNFi) in a pragmatic randomized trial. Primary end point(s): The primary endpoint is non‐inferiority of baricitinib first versus TNFi first in terms of ACR50 response at 12 weeks Timepoint(s) of evaluation of this end point: week 12 SECONDARY OUTCOME: Secondary end point(s): 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). Timepoint(s) of evaluation of this end point: Days 2‐7, week 4, week 8, week 12, week 24, week 36, week 48 INCLUSION CRITERIA: • Clinical diagnosis of RA • Active disease (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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200