Inhibition of JAK Enzymes in early stage Joint inflammatio

Phase 1

• Conditions: Preclinical Phase of rheumatoid arthritis; MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-006562-20-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-08
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Clinical: no arthritis in 76/78 joint count
• Imaging: = 1 B-Mode or PD (Power Doppler) signal with ultrasound at one of the 76/78 joints or 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 allel for RA such as HLA DRB1*01,*02,*03,…*015
• female or male patients, at least 18 and at most 64 years of age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• Clinically apparent arthritis (76/78 joint count)
• Fulfilment of ACR/EULAR 2010 Classification Criteria for RA
• Any previous therapy with bDMARD/tsDMARD/cDMARD
• Ongoing pregnancy status or breast-feeding
• Contraindication for Baricitinib treatment according to its SmPC
• 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)
• Any known VTE risk factor (e.g. previous VTE/LE or inherited coagulation disorder)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified