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NCT Number: NCT03890445

Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly 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.

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Key information

Conditions

Crohn´s Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandoz Investigational Site, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study 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

Acronym: GIANT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2019
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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