Crohn´s DiseaseGIANTNCT03890445
Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease
An observational study of Crohn´s Disease, run by Sandoz at 18 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn´s Disease
- How many people
- 63 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 24 Jun 2019to 8 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
Germany10 sites
Sandoz Investigational Site
Altenholz, 24161
Sandoz Investigational Site
Alzey, 55232
Sandoz Investigational Site
Berlin, 10825
Sandoz Investigational Site
Dachau, 85221
Sandoz Investigational Site
Herne, North Rhine-Westphalia, 44623
Sandoz Investigational Site
Iserlohn, 58644
Sandoz Investigational Site
Jerichow, 39319
Sandoz Investigational Site
Munich, 80331
Sandoz Investigational Site
Münster, 48159
Sandoz Investigational Site
Saarbrücken, 66111
Austria3 sites
Sandoz Investigational Site
Innsbruck, 6020
Sandoz Investigational Site
Salzburg, 5020
Sandoz Investigational Site
Vienna, 1190
Poland2 sites
Sandoz Investigational Site
Piotrkow Trybunalski, 97300
Sandoz Investigational Site
Włocławek, 87-800
Spain2 sites
Sandoz Investigational Site
Ferrol, 15405
Sandoz Investigational Site
Madrid, 28040
About this study
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
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.
- Conditions
- Crohn´s Disease
- Keywords
- Crohn´s Disease, Inflammatory Bowel Disease, Adalimumab, Infliximab, Biosimilar, IBD-Index
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 52
Secondary outcomes (6)
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
Measured: 6 years
Incidence of adverse events
- Incidence of Adverse Events (AE) in patients receiving Hyrimoz™ or Zessly™
Measured: 6 years
Measurement of the Inflamatory Bowel Disease (IBD) index over an observation period
Measured: 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
Measured: 4 years
Assessing QoL (Quality of Life scale) of patients receiving Hyrimoz™ or Zessly™ over an observation period
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start24 Jun 2019
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn´s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890445
- Sponsor's protocol ID
- CGPN017A2001
- Acronym
- GIANT
- Status last verified
- Jun 2021
- First submitted
- 22 Mar 2019
- Last updated
- 18 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03890445
- Acronym / sponsor ID
- GIANT / CGPN017A2001
- Conditions
- Crohn´s Disease
- Keywords
- Crohn´s Disease, Inflammatory Bowel Disease, Adalimumab, Infliximab, Biosimilar, IBD-Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Time to progression of a composite endpoint
Time frame: 6 years
Incidence of adverse events
Time frame: 6 years
Measurement of the Inflamatory Bowel Disease (IBD) index over an observation period
Time frame: 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
Time frame: 4 years
Assessing QoL (Quality of Life scale) of patients receiving Hyrimoz™ or Zessly™ over an observation period
Time frame: 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).
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Study ResultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn´s Disease, run by Sandoz at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, Austria, Poland, Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients in corticosteroid-free remission defined as HBI (Harvey-Bradshow Index) ≤ 4 at Week 52 (time frame: week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.