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
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
April 30, 2022
April 30, 2024
Primary Completion Date
April 30, 2023
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
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
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.