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.
Study Type
OBSERVATIONAL
Enrollment
63
Sandoz Investigational Site
Innsbruck, Austria
Sandoz Investigational Site
Salzburg, Austria
Sandoz Investigational Site
Vienna, Austria
Sandoz Investigational Site
Herne, North Rhine-Westphalia, Germany
Sandoz Investigational Site
Altenholz, Germany
Sandoz Investigational Site
Alzey, Germany
Sandoz Investigational Site
Berlin, Germany
Sandoz Investigational Site
Dachau, Germany
Sandoz Investigational Site
Iserlohn, Germany
Sandoz Investigational Site
Jerichow, Germany
...and 8 more locations
The proportion of patients in corticosteroid-free remission defined as HBI (Harvey-Bradshow Index) ≤ 4 at Week 52
This is a prospective, observational study that does not impose a therapy protocol, diagnostic or therapeutic procedure, or a visit schedule. Patients will be treated according to the local prescribing information, and routine medical practice in terms of visit frequency and types of assessments performed; only these data will be collected as part of the study.
Time frame: week 52
Time to progression of a composite endpoint
Composite endpoint defined as the occurrence of one of the following events : * Disease-related surgery, or * Disease-related hospital admission for \> 3 days (including treatment-related side effects), or * Serious disease-related complications
Time frame: 6 years
Incidence of adverse events
• Incidence of Adverse Events (AE) in patients receiving Hyrimoz™ or Zessly™
Time frame: 6 years
Measurement of the Inflamatory Bowel Disease (IBD) index over an observation period
Time frame: 4 years
Assessing correlation of the diagnostic and treatment-monitoring procedures (imaging procedures and disease-related laboratory parameters) in patients receiving Hyrimoz™ or Zessly™ over an observation period
Time frame: 4 years
Assessing QoL (Quality of Life scale) of patients receiving Hyrimoz™ or Zessly™ over an observation period
Time frame: 4 years
Therapy persistence and treatment adherence (measured by the number of dose interruptions of Hyrimoz™ or Zessly™ without drug holidays more than 4 months).
Observational study
Time frame: 4 years
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