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

Phase 4

Completed

Conditions: Rheumatoid arthritis/ rheumatism
10003816

Registration Number: NL-OMON48248

Lead Sponsor: Overige Centra

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Clinical diagnosis of RA
• Active disease defined a s DAS28> 3.2
• Former treatment according to T2T prin ciples, 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 JAK inhibitor
• Latent or active tuberculosis
• Active or recurrent infections
• 3x upper limit of normal ALAT
• GFR < 30 ml/min.
• Failure to provide written informed consent

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is non-inferiority of tsDAMRD f irst versus TNFi first in<br /><br>terms of ACR50 response at 12 weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* To test for superiority of baricitinib first versus TNFi biological first in<br /><br>c sDMARDs refractory RA patients in terms of ACR response,<br /><br>in case of non-inferiority of baricitinib first.<br /><br>• To evaluate safety of baricitinib versus b iological (TNFi) first in csDMARDs<br /><br>refractory RA patients.<br /><br>• To compare time to first remission and time to persistent remission between<br /><br>treatment arms.<br /><br>• To compare radiographic outcomes between treatment arms.<br /><br>• To compare patient reported outcomes between treatment arm s.<br /><br>• To compare health economical outcomes between treatment arm s.</p><br>