A Study With CIT-013 in RA Patients

Launched by CITRYLL BV · Aug 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CIT-013 to see if it helps reduce the symptoms of rheumatoid arthritis (RA) in adults. The researchers want to find out if CIT-013 can lower the disease activity in patients and understand any side effects that might happen while taking the medication. Participants in the trial will either receive CIT-013 or a placebo (a substance that looks like the drug but has no active ingredients) every two weeks for 12 weeks. They will also visit the clinic every two weeks for checkups and will keep track of their symptoms during this time.

To join this study, participants need to be adults aged 18 to 85 who have been diagnosed with rheumatoid arthritis for at least three months. They should also have specific symptoms and have been stable on certain RA medications for a while. It’s important to note that those with other active inflammatory joint diseases or certain recent treatments may not be eligible. This study is not yet recruiting participants, but if you or someone you know has RA and is interested, it could be a valuable opportunity to help researchers learn more about potential new treatments.

Gender

ALL

Eligibility criteria

• 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
• • At history of at least 3 months treatment and ≥ 4 weeks stable on a conventional synthetic disease modifying antirheumatic drug (csDMARD)
• 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. ≥ 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.