Inhibition of JAK enzymes in early stage joint inflammation

Prior treatment

• Any known VTE risk factor (e.g. previous VTE/LE or inherited coagulation disorder)
• Any previous therapy with bDMARD/tsDMARD/cDMARD
• 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

Other illness

• 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)

Lab values

• Clinically apparent arthritis (76/78 joint count)

Other

• Fulfilment of ACR/EULAR 2010 Classification Criteria for RA
• Any uncontrolled comorbidity
• Contraindication for baricitinib treatment according to its SmPC

• 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): 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 allele for RA such as HLA DRB1*01,*02,*03,*04...*015
• Non-pregnant, non-breastfeeding female patients