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

Crohn´s Disease Clinical Trial

— GIANT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04022083
• Other study ID #: CGPN017A2001
• Status: Recruiting
• Start date: June 24, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2019
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: biopharma.clinicaltrials[@]sandoz.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: June 30, 2025
• Est. primary completion date: May 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

1. Confirmed diagnosis of CD

2. Harvey-Bradshaw Index (HBI) = 5

3. Treatment failure upon steroids / topical budesonide with or without immunosuppressants

4. Males and females = 18 years of age at enrollment

5. 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

6. Provision of signed informed consent form

Exclusion criteria

1. Patients with CD in clinical remission (HBI < 5)

2. Hemoglobin < 8.5 g/dL

3. Patients at imminent risk of scheduled intestinal surgery (stenosis, strictures, internal fistula)

4. Any contraindications to Hyrimoz™ or Zessly™ according to the prescribing recommendations in each country

5. 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)

Related Conditions & MeSH terms

• Crohn Disease
• Crohn´s Disease

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	München

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of adverse events	• Incidence of Adverse Events (AE) in patients receiving Hyrimoz™ or Zessly™	6 years
Secondary	Measurement of the Inflamatory Bowel Disease (IBD) index over an observation period		4 years
Secondary	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
Secondary	Assessing QoL (Quality of Life scale) of patients receiving Hyrimoz™ or Zessly™ over an observation period		4 years
Secondary	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