A Study With CIT-013 in RA Patients

Inclusion criteria

• Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening
• Aged 18-85
• DAS28-CRP ≥ 3.2, with ≥ 3 Swollen Joints, and ≥ 3 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization
• Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.

Exclusion criteria

• High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
• Contra-indication for CIT-013
• Current inflammatory joint disease other than RA (Sjogren with active disease is included).
• The washout period for bDMARD or JAKi prior to the first dose of investigational product should be at least:

• ≥ 1 week for etanercept;
• ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
• ≥ 6 months year for rituximab;
• ≥ 2 weeks for tsDMARD (either investigational or commercially available treatment).
• Treated with ≥ 3 bDMARD or tsDMARD
• Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.