Baricitinib in patients suffering from Rheumatoid Arthritis
- Conditions
- Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT)Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2019-000505-72-NL
- Lead Sponsor
- Transparency in Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 200
•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
•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
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method