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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890445
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Sandoz

Brief 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.


Condition or disease
Crohn´s Disease

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 24, 2019
Actual Primary Completion Date : May 8, 2020
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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



Primary Outcome Measures :
  1. The proportion of patients in corticosteroid-free remission defined as HBI (Harvey-Bradshow Index) ≤ 4 at Week 52 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Time to progression of a composite endpoint [ Time Frame: 6 years ]

    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

  2. Incidence of adverse events [ Time Frame: 6 years ]
    • Incidence of Adverse Events (AE) in patients receiving Hyrimoz™ or Zessly™

  3. Measurement of the Inflamatory Bowel Disease (IBD) index over an observation period [ Time Frame: 4 years ]
  4. 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 ]
  5. Assessing QoL (Quality of Life scale) of patients receiving Hyrimoz™ or Zessly™ over an observation period [ Time Frame: 4 years ]
  6. Therapy persistence and treatment adherence (measured by the number of dose interruptions of Hyrimoz™ or Zessly™ without drug holidays more than 4 months). [ Time Frame: 4 years ]
    Observational study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890445


Contacts
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Contact: Sandoz +41613241111 biopharma.clinicaltrials@sandoz.com
Contact: Sandoz

Locations
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Austria
Sandoz Investigational Site Recruiting
Salzburg, Austria, 5020
Germany
Sandoz Investigational Site Recruiting
Herne, NRW, Germany, 44623
Sandoz Investigational Site Recruiting
Altenholz, Germany, 24161
Sandoz Investigational Site Recruiting
Alzey, Germany, 55232
Sandoz Investigational Site Recruiting
Berlin, Germany, 10825
Sandoz Investigational Site Recruiting
Dachau, Germany, 85221
Sandoz Investigational Site Recruiting
Iserlohn, Germany, 58644
Sandoz Investigational Site Recruiting
Jerichow, Germany, 39319
Sandoz Investigational Site Recruiting
Muenster, Germany, 48159
Sandoz Investigational Site Recruiting
Munich, Germany, 80331
Sandoz Investigational Site Recruiting
Saarbrucken, Germany, 66111
Poland
Sandoz Investigational Site Recruiting
Wloclawek, Poland, 87-800
Sponsors and Collaborators
Sandoz
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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT03890445    
Obsolete Identifiers: NCT03930030, NCT04022083
Other Study ID Numbers: CGPN017A2001
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Keywords provided by Sandoz:
Crohn´s Disease
Inflammatory Bowel Disease
Adalimumab
Infliximab
Biosimilar
IBD-Index
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases