bIosimilar of aDalimumab, an European evAluation
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Age ≥18 years, male or female.
- Patients diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases.
- Patients who have been switched to FK adalimumab from the reference product (Humira®) or another adalimumab biosimilar.
- Patients who have been prescribed FK adalimumab according to the SmPC prior to the inclusion.
- Patients able to understand and complete the study questionnaires in local language during the study visits.
- Patients willing to sign informed consent to meet data protection requirements
EXCLUSION CRITERIA
Exclusion Criteria:
- Unwillingness to provide written informed consent.
- Patients participating or expected to participate in any randomised clinical trial during their treatment with FK adalimumab.
- Patients not expected to be available for study visits during 12 months.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Rheumatoid Arthritis,Ankylosing Spondylitis,Psoriatic Arthritis,Crohn Disease,Ulcerative Colitis
Age (in years)
18+
Participants needed
1050
Est. Completion Date
Apr 30, 2024
Treatment type
Observational
Sponsor
Fresenius Kabi
ClinicalTrials.gov identifier
NCT05190484
Study number
ADAL-004-CNI
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