bIosimilar of aDalimumab, an European evAluation (IDEA)

Fresenius Kabi

Status: Unknown

Conditions: Ulcerative Colitis; Psoriatic Arthritis; Crohn Disease; Ankylosing Spondylitis; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT05190484

ADAL-004-CNI

Details and patient eligibility

About

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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.