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Not Yet Recruiting NCT05633771

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

Conditions: Inflammatory Bowel Disease

Sex: All
Ages: 18 Years – 99 Years
Enrollment: 562
Sponsor: Sandoz

Summary

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

Eligibility Criteria

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 studyExclusion 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05633771). StuddyBuddy aggregates publicly available trial information.