Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Crohn´s Disease

Participation Criteria
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Eligibility Criteria
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The inclusion and exclusion criteria are to ensure the enrollment of patients receiving the drug according to the label of Hyrimoz™ and the label of Zessly™. Patients observed in this study need to meet all of the following inclusion criteria and none of the exclusion criteria at enrollment: Inclusion criteria Confirmed diagnosis of CD Harvey-Bradshaw Index (HBI) ≥ 5 Treatment failure upon steroids / topical budesonide with or without immunosuppressants Males and females ≥ 18 years of age at enrollment Biologic-naive patients scheduled to receive Hyrimoz™ or Zessly™ and patients already receiving Hyrimoz™ or Zessly™ according to the label and at the discretion of the investigator for up to three months prior enrollment Provision of signed informed consent form Exclusion criteria Patients with CD in clinical remission (HBI < 5) Hemoglobin < 8.5 g/dL Patients at imminent risk of scheduled intestinal surgery (stenosis, strictures, internal fistula) Any contraindications to Hyrimoz™ or Zessly™ according to the prescribing recommendations in each country Participation in an interventional clinical trial for immune-mediated inflammatory diseases (IMIDs) or having received any investigational agent or procedure within 30 days prior to enrollment (consenting)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adalimumab Biosimilar (Hyrimoz)<br>Patients with moderate-to-severe CD receiving Hyrimoz™ treatment according to the Hyrimoz™ label at the discretion of the investigator | |
| Infliximab Biosimilar (Zessly)<br>Patients with moderate-to-severe CD receiving Zessly™ treatment according to the Zessly™ label at the discretion of the investigator | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 years | 
| Incidence of adverse events | • Incidence of Adverse Events (AE) in patients receiving Hyrimoz™ or Zessly™ | 6 years | 
| Measurement of the Inflamatory Bowel Disease (IBD) index over an observation period |  | 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 |  | 4 years | 
| Assessing QoL (Quality of Life scale) of patients receiving Hyrimoz™ or Zessly™ over an observation period |  | 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 | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn´s Disease, Inflammatory Bowel Disease, Adalimumab, Infliximab, Biosimilar, IBD-Index