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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Subcutaneous injection
Subcutaneous injection
Subcutaneous injection
CIT-013 medium dose
BE-02
Antwerp, Belgium
WITHDRAWNSite BE-01
Leuven, Belgium
RECRUITINGDE-04
Bamberg, Germany
RECRUITINGDE-05
Berlin, Germany
RECRUITINGDE-01
München, Germany
RECRUITINGDE-02
München, Germany
RECRUITINGDE-03
Ratingen, Germany
WITHDRAWNNL-02
Amsterdam, Netherlands
WITHDRAWNNL-05
Leeuwarden, Netherlands
RECRUITINGNL-04
Leiden, Netherlands
WITHDRAWN...and 14 more locations
The change in DAS28-CRP at week 6 compared to baseline
Efficacy of CIT-013
Time frame: week 6
Incidence of TEAEs as assessed by CTCAE
Safety and tolerability of CIT-013
Time frame: 12 weeks
Maximum Plasma Concentration of CIT-013 before doses
CIT-013 levels
Time frame: 4, 6, 10 and 12 weeks
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