BARICITINIB for Preclinical rheumatoid arthritis | Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Female or male patients, at least 18 and at most 64 years of age\n- Clinical: no arthritis in 76/78 joint count\n- 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\n- Autoantibodies (2 different autoantibodies are compulsory, one of them anti-CCP antibodies): o\tAnti-CCP antibody positivity at screening o\tAnti-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\n- Genetics: HLA status with positive risk allele for RA such as HLA DRB1*01,*02,*03,*04...*015\n- Non-pregnant, non-breastfeeding female patients"}

Exclusion criteria

• {"criterion_text":"- Clinically apparent arthritis (76/78 joint count)\n- Any known VTE risk factor (e.g. previous VTE/LE or inherited coagulation disorder)\n- Fulfilment of ACR/EULAR 2010 Classification Criteria for RA\n- Any previous therapy with bDMARD/tsDMARD/cDMARD\n- Any malignancy risk factor (e.g. current malignancy or history of malignancy)\n- Any active, chronic or recurrent infection\n- Any uncontrolled comorbidity\n- 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\n- Contraindication for baricitinib treatment according to its SmPC\n- 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)"}

Primary endpoints

• {"endpoint_text":"- Number of patients with development of arthritis at week 48","definition_or_measurement_approach":"Assessed at week 48 (method not further specified in available record)"}

Secondary endpoints

• {"endpoint_text":"- Number of patients with development of arthritis at week 24","definition_or_measurement_approach":"Assessed at week 24 (method not further specified)"}
• {"endpoint_text":"- Fulfillment of the ACR/EULAR 2010 RA classification criteria","definition_or_measurement_approach":"Determination of fulfillment of ACR/EULAR 2010 RA criteria (method as per criteria)"}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Ultrasound assessment of PD synovitis/PD tenosynovitis at baseline, week 24 and week 48"}
• {"endpoint_text":"- Safety: (S)AE","definition_or_measurement_approach":"Recording of (serious) adverse events"}
• {"endpoint_text":"- Subjective (SACRAH, sMHQ) and objective (moberg pick up test (MPUT)) hand function","definition_or_measurement_approach":"Assessment using SACRAH, sMHQ questionnaires and Moberg pick up test (MPUT)"}
• {"endpoint_text":"- Change in anti CCP2 antibody levels (RE/ml)","definition_or_measurement_approach":"Measurement of anti-CCP2 antibody levels (RE/ml) over time"}

Germany

Earliest CTIS Part Ii Submission Date

07-05-2024

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

636

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Universitaetsklinikum Erlangen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany