Inhibition of JAK enzymes in early stage joint inflammation
Key facts
- Where
- Erlangen, NémetországSee the site
- Phase
- 2. fázis
Where in Németország
- Universitaetsklinikum Erlangen AöRErlangen, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaetsklinikum Erlangen AöR
- Trial code
- EU 2024-514026-23-00
- Record updated
- 2026. február 2.
- Original description
to evaluate the effect of JAK inhibition with baricitinib in preclinical stage of arthritisRead full original descriptionShow less
JAK Inhibition in PReclinical Arthritis
to evaluate the effect of JAK inhibition with baricitinib in preclinical stage of arthritis
Inclusion: 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.
Exclusion: 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; 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); Clinically apparent arthritis (76/78 joint count); Fulfilment of ACR/EULAR 2010 Classification Criteria for RA; Any uncontrolled comorbidity; Contraindication for baricitinib treatment according to its SmPC.