The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA).
This is an open-label, uncontrolled study in participants with RA. PIT565 will be administered subcutaneously. The objective of the study is to assess the safety of PIT565 in participants with RA.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Study treatment will be provided in vials as open-label participant specific supply.
Novartis Investigative Site
Pilar, Buenos Aires, Argentina
Novartis Investigative Site
CABA, Argentina
Novartis Investigative Site
Sofia, Bulgaria
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Time frame: 6 months
Pharmacokinetic parameters of PIT565: Maximum serum Concentration [Cmax]
Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
Time frame: up to 6 months
Pharmacokinetic parameters of PIT565: Area under serum concentration (AUC)
AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1).
Time frame: up to 6 months
Concentrations of anti-PIT565 antibodies
To assess the immunogenicity (IG) of PIT565
Time frame: Baseline, up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Brest, France
Novartis Investigative Site
Le Kremlin-Bicêtre, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Jena, Thuringia, Germany
Novartis Investigative Site
Mainz, Germany
...and 6 more locations