Clinical trial NCT03890445: Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn´s Disease
Keywords: Crohn´s Disease
Inflammatory Bowel Disease
Adalimumab
Infliximab
Biosimilar
IBD-Index
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2019-03-26
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

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)

Primary outcomes:
measure: The proportion of patients in corticosteroid-free remission defined as HBI (Harvey-Bradshow Index) ≤ 4 at Week 52
timeFrame: week 52
Secondary outcomes:
measure: Time to progression of a composite endpoint
timeFrame: 6 years
measure: Incidence of adverse events
timeFrame: 6 years
measure: Measurement of the Inflamatory Bowel Disease (IBD) index over an observation period
timeFrame: 4 years
measure: 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
timeFrame: 4 years
measure: Assessing QoL (Quality of Life scale) of patients receiving Hyrimoz™ or Zessly™ over an observation period
timeFrame: 4 years
measure: Therapy persistence and treatment adherence (measured by the number of dose interruptions of Hyrimoz™ or Zessly™ without drug holidays more than 4 months).
timeFrame: 4 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Sandoz Investigational Site
city: Salzburg
country: Austria
facility: Sandoz Investigational Site
city: Wien
country: Austria
facility: Sandoz Investigational Site
city: Herne
country: Germany
facility: Sandoz Investigational Site
state: NRW
city: Altenholz
country: Germany
facility: Sandoz Investigational Site
city: Alzey
country: Germany
facility: Sandoz Investigational Site
city: Berlin
country: Germany
facility: Sandoz Investigational Site
city: Dachau
country: Germany
facility: Sandoz Investigational Site
city: Iserlohn
country: Germany
facility: Sandoz Investigational Site
city: Jerichow
country: Germany
facility: Sandoz Investigational Site
city: Muenster
country: Germany
facility: Sandoz Investigational Site
city: Munich
country: Germany
facility: Sandoz Investigational Site
city: Saarbrucken
country: Germany
facility: Sandoz Investigational Site
city: Piotrkow Trybunalski
country: Poland
facility: Sandoz Investigational Site
city: Wloclawek
country: Poland
facility: Sandoz Investigational Site
city: Ferrol
country: Spain
facility: Sandoz Investigational Site
city: Madrid
country: Spain
facility: Sandoz Investigational Site
city: Orebro
country: Sweden
facility: Sandoz Investigational Site
Study officials:
References: