Inhibition of JAK enzymes in early stage joint inflammatio

Phase 1

Recruiting

Conditions: preclinical phase of rheumatoid arthritis
MedDRA version: 23.1Level: PTClassification code: 10039073Term: Rheumatoid arthritis Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: CTIS2024-514026-23-00

Lead Sponsor: niversitaetsklinikum Erlangen AöR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the effect of JAK inhibition with baricitinib in preclinical stage of arthritis;Secondary Objective: to evaluate the effect of serological biomarkers such as pro-inflammatory cytokines, interferon signatures, bone biomarkers in preclinical arthritis, to evaluate safety of baricitinib in preclinical stage of arthritis, to identify (imaging and serological) biomarkers which may predict the course of disease in preclinical stage of arthritis, to evaluate the effect of baricitinib on physical (hand) function in preclinical stage of disease;Primary end point(s): Number of patients with development of arthritis at week 48

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Number of patients with development of arthritis at week 24;Secondary end point(s):Fulfillment of the ACR/EULAR 2010 RA classification criteria;Secondary end point(s):Ultrasound: number of patients without signs of PD synovitis or PD tenosynovitis at week 24 and week 48 compared to baseline and compared within both groups;Secondary end point(s):Safety: (S)AE;Secondary end point(s):Subjective (SACRAH, sMHQ) and objective (moberg pick up test (MPUT)) hand function;Secondary end point(s):Change in anti CCP2 antibody levels (RE/ml)