Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease
NCT ID: NCT03890445
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
63 participants
OBSERVATIONAL
2019-06-24
2020-05-08
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adalimumab Biosimilar (Hyrimoz)
Patients with moderate-to-severe CD receiving Hyrimoz™ treatment according to the Hyrimoz™ label at the discretion of the investigator
No interventions assigned to this group
Infliximab Biosimilar (Zessly)
Patients with moderate-to-severe CD receiving Zessly™ treatment according to the Zessly™ label at the discretion of the investigator
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
80 Years
ALL
No
Sponsors
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Sandoz
INDUSTRY
Responsible Party
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Locations
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Sandoz Investigational Site
Innsbruck, , Austria
Sandoz Investigational Site
Salzburg, , Austria
Sandoz Investigational Site
Vienna, , Austria
Sandoz Investigational Site
Herne, North Rhine-Westphalia, Germany
Sandoz Investigational Site
Altenholz, , Germany
Sandoz Investigational Site
Alzey, , Germany
Sandoz Investigational Site
Berlin, , Germany
Sandoz Investigational Site
Dachau, , Germany
Sandoz Investigational Site
Iserlohn, , Germany
Sandoz Investigational Site
Jerichow, , Germany
Sandoz Investigational Site
Munich, , Germany
Sandoz Investigational Site
Münster, , Germany
Sandoz Investigational Site
Saarbrücken, , Germany
Sandoz Investigational Site
Piotrkow Trybunalski, , Poland
Sandoz Investigational Site
Włocławek, , Poland
Sandoz Investigational Site
Ferrol, , Spain
Sandoz Investigational Site
Madrid, , Spain
Sandoz Investigational Site
Örebro, , Sweden
Countries
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Related Links
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Other Identifiers
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CGPN017A2001
Identifier Type: -
Identifier Source: org_study_id
NCT03930030
Identifier Type: -
Identifier Source: nct_alias
NCT04022083
Identifier Type: -
Identifier Source: nct_alias
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