JAK Inhibition in PReclinical Arthritis - JAKIPRA

niversitätsklinikum Erlangen0 个研究点目标入组 20 人开始时间: 2022年8月8日最近更新: 2024年5月21日

适应症

试验速览

暂无简介。

•Clinical: no arthritis in 76/78 joint count
•Imaging: = 1 B-Mode or PD (Power Doppler) signal with ultrasound at one of the 76/78 joints or flexor/extensor tendons of hand or feet
•Autoantibodies: (2 different Autoantibodies are compulsory, one of them anti-CCP antibodies)
•o Anti-CCP antibody positivity at Screening
•o Anti-modified antibodies: (citrullinated vimentin, citVIM; citrullinated a-enolase, citENO; citrullinated fibrinogen alpha, citFIBa; citrullinated fibrinogen beta, citFIBb) (carbamylated vimentin, carVIM; ornithine acetylated vimentin (ac-orn VIM) and lysine acetylated Vimentin, ac-lys VIM)or RF
•Genetics: HLA Status with positive risk allel for RA such as HLA DRB1*01,*02,*03,…*015
•female or male patients, at least 18 and at most 64 years of age
•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 5

•Clinically apparent arthritis (76/78 joint count)
•Fulfilment of ACR/EULAR 2010 Classification Criteria for RA
•Any previous therapy with bDMARD/tsDMARD/cDMARD
•Ongoing pregnancy status or breast-feeding
•Contraindication for Baricitinib treatment according to its SmPC
•Any malignancy risk factor (e.g. current malignancy or history of malignancy)
•Any active, chronic or recurrent infection
•Any pre-existing condition that constitutes a risk factor for major adverse cardiovascular events (e.g. history of stroke, coronary heart disease, myocardial infarction, current or past long-time smoker)
•Any known VTE risk factor (e.g. previous VTE/LE or inherited coagulation disorder)

发起方

niversitätsklinikum Erlangen