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

Sandoz

Status

Active, not recruiting

Conditions

Inflammatory Bowel Disease

Treatments

Other: Hyrimoz

Study type

Observational

Funder types

Industry

Identifiers

NCT05633771

CGP2017IC01

Details and patient eligibility

About

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

Full 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).

Enrollment

562 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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".