Status:
UNKNOWN
bIosimilar of aDalimumab, an European evAluation
Lead Sponsor:
Fresenius Kabi
Conditions:
Rheumatoid Arthritis
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Brief 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 intestina...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT05190484
Start Date
April 30 2022
End Date
April 30 2024
Last Update
January 13 2022
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