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Clinical Trials in France / NCT05633771
Active, not recruiting Observational

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

NCT05633771 · tracked via the Priya Life Science France tracker
Sponsor
Sandoz
Phase
Observational
Started
2023-02-16
Last updated
2026-01-12

Condition(s) studied

Inflammatory Bowel Disease

Investigational drug(s) / intervention(s)

Hyrimoz

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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".

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
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
Sandoz Investigational Site France Amiens France
Sandoz Investigational Site France Auxerre France
Sandoz Investigational Site France Bayonne France
Sandoz Investigational Site France Beauvais France
Sandoz Investigational Site France Brest France
Sandoz Investigational Site France Caen France
Sandoz Investigational Site France Castelnau-le-Lez France
Sandoz Investigational Site France Clermont-Ferrand France
Sandoz Investigational Site France Clichy France
Sandoz Investigational Site France Cornebarrieu France
Sandoz Investigational Site France Créteil France
Sandoz Investigational Site France Gien France
Sandoz Investigational Site France Le Coudray France
Sandoz Investigational Site France Le Kremlin-Bicêtre France
Sandoz Investigational Site France Lille France
Sandoz Investigational Site France Lyon France
Sandoz Investigational Site France Marseille France
Sandoz Investigational Site France Montpellier France
Sandoz Investigational Site France Nancy France
Sandoz Investigational Site France Neuilly-sur-Seine France
Sandoz Investigational Site France Nice France
Sandoz Investigational Site France Nîmes France
Sandoz Investigational Site France Orléans France
Sandoz Investigational Site France Paris France
Sandoz Investigational Site France Pessac France
Sandoz Investigational Site France Pierre-Bénite France
Sandoz Investigational Site France Poitiers France

+ 11 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05633771 on ClinicalTrials.gov ↗ ← All trials in France