Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.

Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz0 个研究点目标入组 186 人开始时间: 2019年4月11日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1.Patient able to provide informed consent
•2.Mentally competent to understand and willing to undergo the scheduled study procedures, including study questionnaires as established in the protocol.
•3.Female or male, from 18 to 75 years of age at the moment of informed consent signature.
•4.Patient with RA diagnosed according to 2010 ACR/EULAR Classification Criteria for RA.
•5.Moderate to severe disease activity (according to Disease Activity Score for 28 joints (DAS28) = 3.2).
•6.Inadequate response to MTX, which must have been received during, at least, 3 months prior to baseline visit and be on a stable dose of = 25 mg/week.
•7. Patients who fulfils the pre-requisites for biologic and targeted synthetic disease modifying antirheumatic drugs (DMARD) therapy according to National recommendations/regulations (eg, absence of active infections, absence of latent tuberculosis, recommendations regarding previous cancer, vaccination recommendations.
•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 170
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

•1.Patient considered by the investigator to be unsuitable for the study treatment and/or rescue medication (RM) based on the prescription drug labeling, their medical history, physical examination, concomitant medication (CM) and concomitant systemic diseases.
•2.Complications during the period prior to randomisation, in the investigator's opinion.
•3.Hypersensitivity or allergy to the study medication.
•4.Patients taking any concomitant medication, which could be susceptible to interact with the study medication.
•5.Patients in treatment with any medication that could affect the evaluation of the study treatment’s efficacy.
•6.Patients on anticoagulant treatment
•7.Pregnant or lactating women.

发起方

Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz