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A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting
An international, multicenter, non-interventional, prospective, post-authorization, descriptive, non-PASS, study.
The main purpose of this non-interventional study is to assess patient retention with Hyrimoz® treatment up to 6 months after treatment initiation in Inflammatory Bowel Disease (IBD) patients. Primary data will be collected at each data collection time point (visits will be according to local clinical practice). Data will be collected based on the information reported in the medical records. This study does not impose a therapy protocol, procedure or change in routine medical practice. Apart from self-administered questionnaires, no additional examinations or assessments are required, consequently there are no additional medical risks for the patients. The total duration of the study will be 36 months (3 years). The recruitment period will be for 2 years with individual patient follow-up for up to 1 year. It is expected that patients will visit their physicians at regular intervals depending on local specific clinical practices. Four time points for data collection will be defined: * T0 (patient inclusion in the study and Baseline characteristics). * T1 (3-month follow-up ± 1 month). * T2 (6-month follow-up and primary criteria -2/+3 months). * T3 (12-month follow-up -3/+2 months).
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Sandoz Investigational Site Belgium
Aalst, Belgium
Sandoz Investigational Site Belgium
Antwerp, Belgium
Sandoz Investigational Site Belgium
Bonheiden, Belgium
Sandoz Investigational Site Belgium
Brussels, Belgium
Sandoz Investigational Site Belgium
Eeklo, Belgium
Sandoz Investigational Site Belgium
Ghent, Belgium
Sandoz Investigational Site Belgium
Herentals, Belgium
Sandoz Investigational Site Belgium
Kortrijk, Belgium
Sandoz Investigational Site Belgium
Liège, Belgium
Sandoz Investigational Site Belgium
Namur, Belgium
Start Date
February 16, 2023
Primary Completion Date
December 15, 2025
Completion Date
December 1, 2026
Last Updated
January 12, 2026
562
ESTIMATED participants
Hyrimoz
OTHER
Lead Sponsor
Sandoz
NCT06226883
NCT07207200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07245394