Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects(investigator-initiated grant proposal)

Arthritis Alapítvány0 个研究点开始时间: 2015年11月13日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•- Adults (>18 years) male or female
•- Obtained consent from patient in written form
•- Existing rheumatoid arthritis for more than 6 months (DAS28 >3,2), with preceding biological therapy for at least 3 months
•- Patients able to attend to control examinations and fulfil the requirements of protocol
•- Patients able to understand and fill the optional questionnaires
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•- Uncertain diagnosis
•- Severe allergic or anaphylactic raction, or hypersensitivity to any component of tofacitinib
•- Any active or clinically significant recurrent infection
•- Contraindications of tofacitinib therapy (heart failure, SLE, demyelinating diseases, history of malignacy in 10 years, kidney failure, liver failure)
•- Pregnancy
•- History of current symptoms of any untreated disease (e.g. unstable hypertension, diabetes mellitus), which puts the patient at risk in opinion of the investigator doctor
•- Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before the current study begins and/or during study participation.

发起方

Arthritis Alapítvány