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

Last updated: November 28, 2024
Sponsor: Sandoz
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Crohn's Disease (Pediatric)

Ulcerative Colitis

Treatment

Hyrimoz

Clinical Study ID

NCT05633771
CGP2017IC01
  • Ages 18-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ofthese 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 hisphysician before the proposal to participate in the study.

  • Patients meeting one of the following criteria:

  • Referred to as "switched patients": Patients treated continuously withadalimumab (other than Hyrimoz®) for at least 6 months, with an indication forcontinuing treatment with adalimumab at any therapeutic dose (physician'sdecision) and who have controlled stable disease for at least 3 months beforestudy enrollment (according to the physician's criteria).

  • Referred to as "biologic-naive patients": Patients who had an inadequateresponse or contraindications to conventional therapy with no exposure to anybiological medicine and targeted therapies and started Hyrimoz® as a first-linebiologic 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 perlocal regulations prior to participation in the study

Exclusion

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 forless than 3 months, in case of "switched patient".

Study Design

Total Participants: 562
Treatment Group(s): 1
Primary Treatment: Hyrimoz
Phase:
Study Start date:
February 16, 2023
Estimated Completion Date:
December 31, 2026

Study Description

The main purpose of this non-interventional study is to assess patient retention with Hyrimoz® treatment up to 6 months after treatment initiation in Inflammatory Bowel Disease (IBD) patients.

Primary data will be collected at each data collection time point (visits will be according to local clinical practice). Data will be collected based on the information reported in the medical records. This study does not impose a therapy protocol, procedure or change in routine medical practice. Apart from self-administered questionnaires, no additional examinations or assessments are required, consequently there are no additional medical risks for the patients. The total duration of the study will be 36 months (3 years). The recruitment period will be for 2 years with individual patient follow-up for up to 1 year.

It is expected that patients will visit their physicians at regular intervals depending on local specific clinical practices. Four time points for data collection will be defined:

  • T0 (patient inclusion in the study and Baseline characteristics).

  • T1 (3-month follow-up ± 1 month).

  • T2 (6-month follow-up and primary criteria -2/+3 months).

  • T3 (12-month follow-up -3/+2 months).

Connect with a study center

  • Sandoz Investigational Site Belgium

    Bonheiden,
    Belgium

    Active - Recruiting

  • Sandoz Investigational Site Belgium

    Bruxelles,
    Belgium

    Active - Recruiting

  • Sandoz Investigational Site France

    Auxerre,
    France

    Active - Recruiting

  • Sandoz Investigational Site France

    Clichy,
    France

    Active - Recruiting

  • Sandoz Investigational Site France

    Nîmes,
    France

    Active - Recruiting

  • Sandoz Investigational Site France

    Rennes,
    France

    Active - Recruiting

  • Sandoz Investigational Site

    Toulouse,
    France

    Active - Recruiting

  • Sandoz Investigational Site France

    Toulouse,
    France

    Active - Recruiting

  • Sandoz Investigational Site France

    Troyes,
    France

    Active - Recruiting

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