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

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

ClinicalTrials.gov Identifier: NCT03890445

Novartis Reference Number: CGPN017A2001

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Crohn´s Disease
Phase 
Not Given
Overall status 
Recruiting
Enrollment count 
1600 participants
Start date 
Jun 24, 2019
Completion date 
Jun 30, 2025
Gender 
All
Age(s)
18 Years - 80 Years (Adult, Older Adult)

Eligibility Criteria

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)

Study Locations

Austria
Sandoz Investigational Site
Recruiting
Salzburg, 5020
-
Austria
Germany
Sandoz Investigational Site
Recruiting
Herne, 44623
NRW
Germany
Sandoz Investigational Site
Recruiting
Altenholz, 24161
-
Germany
Sandoz Investigational Site
Recruiting
Alzey, 55232
-
Germany
Sandoz Investigational Site
Recruiting
Berlin, 10825
-
Germany
Sandoz Investigational Site
Recruiting
Dachau, 85221
-
Germany
Sandoz Investigational Site
Recruiting
Iserlohn, 58644
-
Germany
Sandoz Investigational Site
Recruiting
Jerichow, 39319
-
Germany
Sandoz Investigational Site
Recruiting
Muenster, 48159
-
Germany
Sandoz Investigational Site
Recruiting
Munich, 80331
-
Germany
Sandoz Investigational Site
Recruiting
Saarbrucken, 66111
-
Germany
Poland
Sandoz Investigational Site
Recruiting
Wloclawek, 87-800
-
Poland

Contacts

Name: 
Sandoz
Phone: 
Name: 
Sandoz
Phone: 
Email: 

Have a question?

Call 1-888-669-6682 or email [email protected]