Phase
Condition
Gastrointestinal Diseases And Disorders
Crohn's Disease (Pediatric)
Ulcerative Colitis
Treatment
Hyrimoz
Clinical Study ID
Ages 18-99 All Genders
Study Summary
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
Study Description
Connect with a study center
Sandoz Investigational Site Belgium
Bonheiden,
BelgiumActive - Recruiting
Sandoz Investigational Site Belgium
Bruxelles,
BelgiumActive - Recruiting
Sandoz Investigational Site France
Auxerre,
FranceActive - Recruiting
Sandoz Investigational Site France
Clichy,
FranceActive - Recruiting
Sandoz Investigational Site France
Nîmes,
FranceActive - Recruiting
Sandoz Investigational Site France
Rennes,
FranceActive - Recruiting
Sandoz Investigational Site
Toulouse,
FranceActive - Recruiting
Sandoz Investigational Site France
Toulouse,
FranceActive - Recruiting
Sandoz Investigational Site France
Troyes,
FranceActive - Recruiting
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