Last Update: Apr 24, 2023
A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting Identifier:
Novartis Reference Number:CGP2017IC01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Inflammatory Bowel Disease
Feb 16, 2023
Dec 15, 2025
18 Years - 99 Years (Adult, Older Adult)




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

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.

Study Location

Sandoz Investigational Site



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