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ACTIVE NOT RECRUITING

NCT05633771

Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting

Sponsor: Sandoz

View on ClinicalTrials.gov

Summary

An international, multicenter, non-interventional, prospective, post-authorization, descriptive, non-PASS, study.

Official title: A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

562

Start Date

2023-02-16

Completion Date

2026-12

Last Updated

2026-01-12

Healthy Volunteers

Conditions

Inflammatory Bowel Disease

Interventions

OTHER

Hyrimoz

There is no treatment allocation. Patients administered Hyrimoz by prescription that have started as routine medical treatment will be enrolled.

Inclusion Criteria: Patients must meet all of the following criteria at Baseline: * Patients initiating Hyrimoz® treatment. * Patients with a confirmed diagnosis (following local recommendations) of one of these indications: CD or UC. * Patients ≥ 18 years of age. * Patient in whom the decision to initiate Hyrimoz® (naïve population) or to switch (switch population) from reference adalimumab to Hyrimoz® was accorded with his physician before the proposal to participate in the study. * Patients meeting one of the following criteria: * Referred to as "switched patients": Patients treated continuously with adalimumab (other than Hyrimoz®) for at least 6 months, with an indication for continuing treatment with adalimumab at any therapeutic dose (physician's decision) and who have controlled stable disease for at least 3 months before study enrollment (according to the physician's criteria). * Referred to as "biologic-naive patients": Patients who had an inadequate response or contraindications to conventional therapy with no exposure to any biological medicine and targeted therapies and started Hyrimoz® as a first-line biologic therapy according to the summary of product characteristics (SmPC). * Patients able to complete and understand the self-administered questionnaires. * Patients who have been informed and have provided a signed written consent as per local regulations prior to participation in the study Exclusion Criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: * Patients enrolled in an ongoing interventional study. * Patients with any contraindications to Hyrimoz® according to the SmPC. * Patients at imminent risk of scheduled intestinal surgery (stenosis, strictures, internal fistula). * Use of any investigational drug in last 6 months prior to enrollment. * Patient received any biological medicine or targeted therapy, in case of " biologic-naive patient ", * Patient received adalimumab for less than 6 months or have controlled disease for less than 3 months, in case of "switched patient".

Locations (51)

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

Sandoz Investigational Site Belgium

Seraing, Belgium

Sandoz Investigational Site Belgium

Sint-Niklaas, Belgium

Sandoz Investigational Site Belgium

Tongeren, Belgium