bIosimilar of aDalimumab, an European evAluation

An International, Prospective, Observational Study of Patients With Chronic Inflammatory Diseases, to Assess 12-months Persistence Drivers After Switching to an Adalimumab Biosimilar, Idacio®, in a Real World Setting

NCT05190484•Fresenius Kabi

View on ClinicalTrials.gov

Summary

The study objective is aimed to describe all country, site, investigator and patient variables that lead to treatment persistence for at least 12 months among patients with rheumatologic and intestinal chronic inflammatory diseases who were switched to FK adalimumab, in order to develop a model to predict persistence at 12 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years, male or female.
•2. Patients diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases.
•3. Patients who have been switched to FK adalimumab from the reference product (Humira®) or another adalimumab biosimilar.
•4. Patients who have been prescribed FK adalimumab according to the SmPC prior to the inclusion.
•5. Patients able to understand and complete the study questionnaires in local language during the study visits.
•6. Patients willing to sign informed consent to meet data protection requirements

Exclusion Criteria

•1. Unwillingness to provide written informed consent.
•2. Patients participating or expected to participate in any randomised clinical trial during their treatment with FK adalimumab.
•3. Patients not expected to be available for study visits during 12 months.

Key Dates

Start Date

April 30, 2022

Primary Completion Date

April 30, 2023

Completion Date

April 30, 2024

Last Updated

January 13, 2022

Enrollment

1,050

ESTIMATED participants

Conditions

Rheumatoid ArthritisAnkylosing SpondylitisPsoriatic ArthritisCrohn DiseaseUlcerative Colitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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bIosimilar of aDalimumab, an European evAluation

Inclusion Criteria

Exclusion Criteria

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