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

Launched by SANDOZ · Nov 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Hyrimoz® in patients with Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's Disease (CD) and Ulcerative Colitis (UC). The goal of the study is to see how well patients stick with this treatment in real-life settings. The trial is open to adults aged 18 and older who are either starting Hyrimoz® for the first time or switching from another similar medication called adalimumab. To join, patients must have a confirmed diagnosis of IBD and meet specific health criteria that their doctor agrees with.

Participants in this study will have the opportunity to share their experiences through questionnaires, which will help researchers understand how effective and well-tolerated Hyrimoz® is. It’s important to note that patients who are currently involved in other clinical trials, or who have certain health issues, may not be eligible to participate. Overall, this trial aims to gather valuable information that could help improve treatment options for people living with IBD.

Gender

ALL

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 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".