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New study tracks IBD patients on biosimilar drug hyrimoz®

NCT ID NCT05633771

Knowledge-focused Sponsor: Sandoz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observes 562 adults with inflammatory bowel disease (Crohn's disease or ulcerative colitis) who are starting or switching to Hyrimoz®, a biosimilar of adalimumab. Researchers will track how many patients continue the treatment after 6 months and why some stop, such as lack of effect, side effects, or personal choice. The goal is to understand real-world use, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 562 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients for whom the investigator has decided to initiate treatment with Hyrimoz® in accordance with the approved SmPC and local clinical practice, will be eligible to participate in the study.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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".

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory bowel disease

Contacts and locations

Locations

  • 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

  • Sandoz Investigational Site France

    Pringy, France

  • Sandoz Investigational Site France

    Reims, France

  • Sandoz Investigational Site France

    Rennes, France

  • Sandoz Investigational Site France

    Saint-Etienne, France

  • Sandoz Investigational Site France

    Saint-Nazaire, France

  • Sandoz Investigational Site France

    Sarrebourg, France

  • Sandoz Investigational Site France

    Toulouse, France

  • Sandoz Investigational Site France

    Tours, France

  • Sandoz Investigational Site France

    Troyes, France

  • Sandoz Investigational Site France

    Vandœuvre-lès-Nancy, France

  • Sandoz Investigational Site France

    Vénissieux, France

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