Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting
NCT ID: NCT05633771
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
562 participants
OBSERVATIONAL
2023-02-16
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
NCT01848561
Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)
NCT05372939
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
NCT05611671
VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study (DOPER)
NCT05158517
Evaluation of the Safety and Effectiveness of Switching From Humira® to Imraldi® in Flanders
NCT04045782
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hyrimoz
Patients prescribed with Hyrimoz
Hyrimoz
There is no treatment allocation. Patients administered Hyrimoz by prescription that have started as routine medical treatment will be enrolled.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hyrimoz
There is no treatment allocation. Patients administered Hyrimoz by prescription that have started as routine medical treatment will be enrolled.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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".
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sandoz
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sandoz Investigational Site Belgium
Aalst, , Belgium
Sandoz Investigational Site Belgium
Antwerp, , Belgium
Sandoz Investigational Site Belgium
Bonheiden, , Belgium
Sandoz Investigational Site Belgium
Brussels, , Belgium
Sandoz Investigational Site Belgium
Eeklo, , Belgium
Sandoz Investigational Site Belgium
Ghent, , Belgium
Sandoz Investigational Site Belgium
Herentals, , Belgium
Sandoz Investigational Site Belgium
Kortrijk, , Belgium
Sandoz Investigational Site Belgium
Liège, , Belgium
Sandoz Investigational Site Belgium
Namur, , Belgium
Sandoz Investigational Site Belgium
Seraing, , Belgium
Sandoz Investigational Site Belgium
Sint-Niklaas, , Belgium
Sandoz Investigational Site Belgium
Tongeren, , Belgium
Sandoz Investigational Site France
Amiens, , France
Sandoz Investigational Site France
Auxerre, , France
Sandoz Investigational Site France
Bayonne, , France
Sandoz Investigational Site France
Beauvais, , France
Sandoz Investigational Site France
Brest, , France
Sandoz Investigational Site France
Caen, , France
Sandoz Investigational Site France
Castelnau-le-Lez, , France
Sandoz Investigational Site France
Clermont-Ferrand, , France
Sandoz Investigational Site France
Clichy, , France
Sandoz Investigational Site France
Cornebarrieu, , France
Sandoz Investigational Site France
Créteil, , France
Sandoz Investigational Site France
Gien, , France
Sandoz Investigational Site France
Le Coudray, , France
Sandoz Investigational Site France
Le Kremlin-Bicêtre, , France
Sandoz Investigational Site France
Lille, , France
Sandoz Investigational Site France
Lyon, , France
Sandoz Investigational Site France
Marseille, , France
Sandoz Investigational Site France
Montpellier, , France
Sandoz Investigational Site France
Nancy, , France
Sandoz Investigational Site France
Neuilly-sur-Seine, , France
Sandoz Investigational Site France
Nice, , France
Sandoz Investigational Site France
Nîmes, , France
Sandoz Investigational Site France
Orléans, , France
Sandoz Investigational Site France
Paris, , France
Sandoz Investigational Site France
Pessac, , France
Sandoz Investigational Site France
Pierre-Bénite, , France
Sandoz Investigational Site France
Poitiers, , France
Sandoz Investigational Site France
Pringy, , France
Sandoz Investigational Site France
Reims, , France
Sandoz Investigational Site France
Rennes, , France
Sandoz Investigational Site France
Saint-Etienne, , France
Sandoz Investigational Site France
Saint-Nazaire, , France
Sandoz Investigational Site France
Sarrebourg, , France
Sandoz Investigational Site France
Toulouse, , France
Sandoz Investigational Site France
Tours, , France
Sandoz Investigational Site France
Troyes, , France
Sandoz Investigational Site France
Vandœuvre-lès-Nancy, , France
Sandoz Investigational Site France
Vénissieux, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CGP2017IC01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.