P497 Injection site reactions and injection site pain for the adalimumab biosimilar ABP 501: Results from two double-blind, randomised, controlled studies
نویسندگان
چکیده
منابع مشابه
Aluminium and injection site reactions.
AIMS To alert pathologists to the spectrum of histological appearances that may be seen in injection site reactions related to aluminium. METHODS Four cases of injection site reaction were examined microscopically using routine staining with haematoxylin and eosin, electron microscopy and by electron probe microanalysis. RESULTS As in previous reports, all four cases included collections of...
متن کاملEfficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study
OBJECTIVES ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. METHODS In this randomised, double-blind, active comparator-controlled, 26-week equivalen...
متن کاملstudy of the effect of Z-track intramuscular injection on severity of pain,bruises ,and drug leakage at injection site
the purpose of this quasi-experimental study was to examine the effect of the Z-track intramuscular injection technique on severity of pain,bruises and drug leakage at the injection site.the subjects of the study were 60 adult medical-surgical patients at Kerman university of medical sciences hospitals.subjects served as their own controls by receiving both z-track and standard intramuscular i...
متن کاملVaccine-related pain: randomised controlled trial of two injection techniques.
OBJECTIVE To compare acute pain response during immunisation in infants using a slow standard of care injection technique versus a rapid pragmatic technique. DESIGN Randomised controlled trial. SETTING Single-centre, urban paediatric primary care practice. SUBJECTS Healthy infants 4-6 months of age receiving their routine DPTaP-Hib immunisation. INTERVENTIONS Standard of care group: slo...
متن کاملA randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab
OBJECTIVE To demonstrate pharmacokinetic (PK) similarity of biosimilar candidate ABP 501 relative to adalimumab reference product from the USA and European Union (EU) and evaluate safety, tolerability and immunogenicity of ABP 501. METHODS Randomised, single-blind, single-dose, three-arm, parallel-group study; healthy subjects were randomised to receive ABP 501 (n=67), adalimumab (USA) (n=69)...
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ژورنال
عنوان ژورنال: Journal of Crohn's and Colitis
سال: 2018
ISSN: 1873-9946,1876-4479
DOI: 10.1093/ecco-jcc/jjx180.624