NCT05633771|Active Not Recruiting

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

HYRISS

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

Sandoz ClinicalTrials.gov

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1 other identifier

CGP2017IC01

Study Type

observational

Target

562

Locations

2 countries

Sites

Timeline

RegisteredDec 2022

StartedFeb 2023

CompletionDec 2026

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

562

participants targeted

Target at P75+ for all trials

Timeline

7mo left

Started Feb 2023

Typical duration for all trials

Geographic Reach

2 countries

51 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

Study Progress85%

Feb 2023Dec 2026

First Submitted

Initial submission to the registry

November 21, 2022

Completed

10 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed

3 months until next milestone

Study Start

First participant enrolled

February 16, 2023

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected

Last Updated

January 12, 2026

Status Verified

October 1, 2025

Enrollment Period

2.8 years

First QC Date

November 21, 2022

Last Update Submit

January 9, 2026

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel DiseaseIBDNISHYRISSadalimumabHyrimoz

Outcome Measures

Primary Outcomes (1)

Percentage of patients who remain on Hyrimoz® at 6 months after treatment initiation
Assess patient retention with Hyrimoz® treatment up to 6 months after treatment initiation
Up to 6 months

Secondary Outcomes (9)

Percentage of patients who discontinue Hyrimoz
6 months, 12 months
Percentage of patients with high level of treatment satisfaction using TSQM-9 questionnaire
3 months, 6 months, 12 months
Percentage of patients with high level of treatment adherence using adapted CQR5 questionnaire
Baseline, 3 months, 6 months, 12 months
Percentage of patients with the perception of a high level of disease activity using VAS scale
Baseline, 3 months, 6 months, 12 months
Percentage of patients with a good perception about biosimilars using VAS scale
Baseline
+4 more secondary outcomes

Study Arms (1)

Hyrimoz

Patients prescribed with Hyrimoz

Other: Hyrimoz

Interventions

HyrimozOTHER

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

Also known as: adalimumab biosimilar

Hyrimoz

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sandozlead

Study Sites (51)

Sandoz Investigational Site Belgium

Aalst, Belgium

Location

Sandoz Investigational Site Belgium

Antwerp, Belgium

Location

Sandoz Investigational Site Belgium

Bonheiden, Belgium

Location

Sandoz Investigational Site Belgium

Brussels, Belgium

Location

Sandoz Investigational Site Belgium

Eeklo, Belgium

Location

Sandoz Investigational Site Belgium

Ghent, Belgium

Location

Sandoz Investigational Site Belgium

Herentals, Belgium

Location

Sandoz Investigational Site Belgium

Kortrijk, Belgium

Location

Sandoz Investigational Site Belgium

Liège, Belgium

Location

Sandoz Investigational Site Belgium

Namur, Belgium

Location

Sandoz Investigational Site Belgium

Seraing, Belgium

Location

Sandoz Investigational Site Belgium

Sint-Niklaas, Belgium

Location

Sandoz Investigational Site Belgium

Tongeren, Belgium

Location