Informations générales (source: ClinicalTrials.gov)
A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting (HYRISS)
Observational
Sandoz (Voir sur ClinicalTrials)
février 2023
décembre 2026
21 septembre 2024
An international, multicenter, non-interventional, prospective, post-authorization,
descriptive, non-PASS, study.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Mathias VIDON | 29/03/2024 01:30:28 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Sandoz Investigational Site France - Auxerre - France | Contact (sur clinicalTrials) | ||||
| Sandoz Investigational Site France - Clichy - France | Contact (sur clinicalTrials) | ||||
| Sandoz Investigational Site France - Nîmes - France | Contact (sur clinicalTrials) | ||||
| Sandoz Investigational Site France - Rennes - France | Contact (sur clinicalTrials) | ||||
| Sandoz Investigational Site France - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Sandoz Investigational Site France - Troyes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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".