Crohn´s Disease Clinical Trial
Official title:
GIANT - A Multicenter, Prospective, Observational Study of Real-world Anti-TNFa Treatment Regimens of Hyrimoz™ (Adalimumab Biosimilar) or Zessly™ (Infliximab Biosimilar) in Patients With Crohn's Disease
Hyrimoz™ was developed as a biosimilar to HumiraTM (INN: adalimumab) and Zessly™ was
developed as a biosimilar to RemicadeTM (INN: infliximab). Within the Biosimilar Development
Program of Hyrimoz™ and Zessly™, two clinical confirmatory efficacy and safety studies were
conducted: Hyrimoz™ in plaque psoriasis and Zessly™ in rheumatoid arthritis. Both
confirmatory Phase III studies demonstrated equivalent efficacy and similar safety and
immunogenicity of Hyrimoz™ to HumiraTM and Zessly™ to RemicadeTM, respectively.
The current study is designed to provide a systematic and consistent overview of the
real-world data in biologic-naïve patients with moderate-to-severe Crohn's disease (CD). The
data collected in this observational trial will be used to increase the knowledge of the
effectiveness of Hyrimoz™ and Zessly™ in clinical routine care in patients with
moderate-to-severe CD.
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