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

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.

Study Overview

• Status: Completed
• Conditions: Crohn´s Disease

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Sandoz Investigational Site
  • Salzburg, Austria, 5020
    • Sandoz Investigational Site
  • Wien, Austria, 1190
    • Sandoz Investigational Site
• Germany
  • Altenholz, Germany, 24161
    • Sandoz Investigational Site
  • Alzey, Germany, 55232
    • Sandoz Investigational Site
  • Berlin, Germany, 10825
    • Sandoz Investigational Site
  • Dachau, Germany, 85221
    • Sandoz Investigational Site
  • Iserlohn, Germany, 58644
    • Sandoz Investigational Site
  • Jerichow, Germany, 39319
    • Sandoz Investigational Site
  • Muenster, Germany, 48159
    • Sandoz Investigational Site
  • Munich, Germany, 80331
    • Sandoz Investigational Site
  • Saarbrucken, Germany, 66111
    • Sandoz Investigational Site
  • NRW
    • Herne, NRW, Germany, 44623
      • Sandoz Investigational Site
• Poland
  • Piotrkow Trybunalski, Poland, 97300
    • Sandoz Investigational Site
  • Wloclawek, Poland, 87-800
    • Sandoz Investigational Site
• Spain
  • Ferrol, Spain, 15405
    • Sandoz Investigational Site
  • Madrid, Spain, 28040
    • Sandoz Investigational Site
• Sweden
  • Orebro, Sweden, 701 85
    • Sandoz Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

It is planned to enroll a total of 1,600 patients.

The following patient groups will be observed:

• Patients with moderate-to-severe CD receiving Hyrimoz™ treatment according to the Hyrimoz™ label at the discretion of the investigator
• Patients with moderate-to-severe CD receiving Zessly™ treatment according to the Zessly™ label at the discretion of the investigator

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Adalimumab Biosimilar (Hyrimoz); Patients with moderate-to-severe CD receiving Hyrimoz™ treatment according to the Hyrimoz™ label at the discretion of the investigator
Infliximab Biosimilar (Zessly); 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?

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

Collaborators and Investigators

• Sponsor: Sandoz

Publications and helpful links

Helpful Links

• Study Results

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): May 8, 2020
• Study Completion (Actual): May 8, 2020

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; Infliximab; Adalimumab; Biosimilar; Crohn´s Disease; IBD-Index
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: CGPN017A2001