Rheumatoid Arthritis
Conditions
Brief summary
The goal of this clinical trial is to learn if CIT-013 works to treat rheumatoid arthritis in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are: Does CIT-013 lower the disease activity of RA patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of RA. Participants will: Take receive CIT-013 or placebo every other week for 6 weeks and 50 mg CIT-013 for 6 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period
Interventions
DRUGCIT-013 low dose
Subcutaneous injection
Subcutaneous injection
DRUGPlacebo
Subcutaneous injection
CIT-013 medium dose
Sponsors
Citryll BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. ≥ 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in DAS28-CRP at week 6 compared to baseline | week 6 | Efficacy of CIT-013 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of TEAEs as assessed by CTCAE | 12 weeks | Safety and tolerability of CIT-013 |
| Maximum Plasma Concentration of CIT-013 before doses | 4, 6, 10 and 12 weeks | CIT-013 levels |
Countries
Belgium, Germany, Netherlands, Poland, Spain
Contacts
CONTACTLeonie Middelink
STUDY_DIRECTORMaarten Kraan
Citryll BV
Outcome results
None listed