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.
You may not be if
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. ≥ 1 week for etanercept;
2. ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
3. ≥ 6 months year for rituximab;
4. ≥ 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.
Clareo Health | A Study With CIT-013 in RA Patients
