Clinical trial NCT05633771: Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting
Official title: A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Disease
Keywords: Inflammatory Bowel Disease
IBD
NIS
HYRISS
adalimumab
Hyrimoz
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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

Detailed 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).

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".

Primary outcomes:
measure: Percentage of patients who remain on Hyrimoz® at 6 months after treatment initiation
timeFrame: Up to 6 months
Secondary outcomes:
measure: Percentage of patients who discontinue Hyrimoz
timeFrame: 6 months, 12 months
measure: Percentage of patients with high level of treatment satisfaction using TSQM-9 questionnaire
timeFrame: 3 months, 6 months, 12 months
measure: Percentage of patients with high level of treatment adherence using adapted CQR5 questionnaire
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Percentage of patients with the perception of a high level of disease activity using VAS scale
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Percentage of patients with a good perception about biosimilars using VAS scale
timeFrame: Baseline
measure: Percentage of patients in remission
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Crohn's disease activity measurement: Harvey Bradshaw Index [HBI]
timeFrame: Up to 12 months
measure: Ulcerative colitis activity measurement: partial Mayo calculation score
timeFrame: Up to 12 months
measure: Pattern of Hyrimoz® utilization
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Sandoz Investigational Site Belgium
city: Bruxelles
country: Belgium
facility: Sandoz Investigational Site Belgium
city: Auxerre
country: France
facility: Sandoz Investigational Site France
city: Clichy
country: France
facility: Sandoz Investigational Site France
city: Nîmes
country: France
facility: Sandoz Investigational Site France
city: Rennes
country: France
facility: Sandoz Investigational Site France
city: Toulouse
country: France
facility: Sandoz Investigational Site France
city: Troyes
country: France
facility: Sandoz Investigational Site France
Study officials:
References: