JAK Inhibition in PReclinical Arthritis

niversitaetsklinikum Erlangen AöR0 个研究点目标入组 20 人开始时间: 2024年5月8日最近更新: 2024年7月22日

适应症

试验速览

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•Female or male patients, at least 18 and at most 64 years of age, Clinical: no arthritis in 76/78 joint count, Imaging: = 1 B-Mode or Power Doppler signal with ultrasound at one of the 76/78 joints of flexor/extensor tendons of hand or feet, Autoantibodies (2 different autoantibodies are compulsory, one of them anti-CCP antibodies): oAnti-CCP antibody positivity at screening oAnti-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 allele for RA such as HLA DRB1*01,*02,*03,*04...*015, Non-pregnant, non-breastfeeding female patients

•Clinically apparent arthritis (76/78 joint count), Any known VTE risk factor (e.g. previous VTE/LE or inherited coagulation disorder), Fulfilment of ACR/EULAR 2010 Classification Criteria for RA, Any previous therapy with bDMARD/tsDMARD/cDMARD, Any malignancy risk factor (e.g. current malignancy or history of malignancy), Any active, chronic or recurrent infection, Any uncontrolled comorbidity, Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months or according to local guidelines prior to screening and evaluated by a qualified physician, Contraindication for baricitinib treatment according to its SmPC, 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)

发起方

niversitaetsklinikum Erlangen AöR