A Study With CIT-013 in RA Patients
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT06567470
- Lead Sponsor
- Citryll BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Male or female patients with RA according to the 2010 classification criteria of the<br> American College of Rheumatology (ACR) and the European League Against Rheumatism<br> (EULAR) = 3 months prior to screening<br><br> - Aged 18-85<br><br> - DAS28-CRP = 3.2, with = 2 Swollen Joints, and = 2 Tender Joints, and CRP = ULN at<br> screening and confirmed prior to randomization<br><br> - At history of at least 3 months treatment and = 4 weeks stable on a conventional<br> synthetic disease modifying antirheumatic drug (csDMARD)<br><br>Exclusion Criteria:<br><br> - Contra-indication for CIT-013<br><br> - Current inflammatory joint disease other than RA (Sjogren with active disease is<br> included).<br><br> - The washout period for bDMARD or JAKi prior to the first dose of investigational<br> product should be at least:<br><br> 1. = 1 week for etanercept;<br><br> 2. = 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept,<br> tocilizumab, and sarilumab;<br><br> 3. = 6 months year for rituximab;<br><br> 4. = 2 weeks for tsDMARD (either investigational or commercially available<br> treatment).<br><br> - Treated with = 3 bDMARD or tsDMARD<br><br> - Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone<br> or equivalent within 4 weeks prior to screening.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in DAS28-CRP at week 12 compared to baseline
- Secondary Outcome Measures
Name Time Method Incidence of TEAEs as assessed by CTCAE;Maximum Plasma Concentration of CIT-013 before doses