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About
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 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period
Enrollment
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Inclusion criteria
Exclusion criteria
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:
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.
Primary purpose
Allocation
Interventional model
Masking
150 participants in 3 patient groups, including a placebo group
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Central trial contact
Leonie Middelink
Data sourced from clinicaltrials.gov
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