Assessing how well patients with Inflammatory Bowel Disease stick to Hyrimoz® treatment

A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting

This study looks at how well people with Inflammatory Bowel Disease stick with the Hyrimoz® treatment over six months, whether they are new to biologics or switching from another medication.

Quick facts

• Study type: Observational
• Enrollment: 562 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Sandoz (Industry-sponsored)
• Drugs / interventions: adalimumab
• Locations: 8 sites (Bonheiden and 7 other locations)
• Trial ID: NCT05633771 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the retention of patients with Inflammatory Bowel Disease (IBD) on Hyrimoz®, a biosimilar to adalimumab, over a period of up to 6 months after starting treatment. It will collect primary data at various time points based on routine clinical practice without imposing any additional medical procedures or risks. Patients will be followed for a total of 36 months, with data collected at baseline, 3 months, 6 months, and 12 months. The study focuses on both biologic-naive patients and those switching from reference adalimumab to Hyrimoz®.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are initiating Hyrimoz® treatment or switching from reference adalimumab with a stable disease condition.

Not a fit: Patients who are not initiating Hyrimoz® treatment or those with uncontrolled disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness and patient adherence to Hyrimoz® treatment in real-world settings for IBD patients.

How similar studies have performed: Other studies assessing treatment retention with biosimilars have shown promising results, indicating that this approach is supported by previous findings.

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".

Where this trial is running

Bonheiden and 7 other locations

• Sandoz Investigational Site Belgium — Bonheiden, Belgium (Recruiting)
• Sandoz Investigational Site Belgium — Bruxelles, Belgium (Recruiting)
• Sandoz Investigational Site France — Auxerre, France (Recruiting)
• Sandoz Investigational Site France — Clichy, France (Recruiting)
• Sandoz Investigational Site France — Nîmes, France (Recruiting)
• Sandoz Investigational Site France — Rennes, France (Recruiting)
• Sandoz Investigational Site France — Toulouse, France (Recruiting)
• Sandoz Investigational Site France — Troyes, France (Recruiting)

Study contacts

• Study coordinator: Sandoz

Conditions Inflammatory Bowel Disease; IBD; NIS; HYRISS; adalimumab; Hyrimoz