Baricitinib in patients suffering from Rheumatoid Arthritis

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000505-72-NL

Enrollment

200

Registered

2019-02-18

Start date

2019-05-13

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Olumiant Product Name: baricitinib Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Primary

Measure	Time frame
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. ; 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. ;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	—

Measure

Time frame

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. ; 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. ;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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Netherlands

Contacts

Public ContactClinical Trial Manager

Transparency in Healthcare

d.i.tedjo@tihealthcare.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026