bIosimilar of aDalimumab, an European evAluation

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

• Registration Number: NCT05190484
• Lead Sponsor: Fresenius Kabi

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 intestinal chronic inflammatory diseases who were switched to FK adalimumab, in order to develop a model to predict persistence at 12 months.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13
• Study Start: 2022-04-30
• Primary Completion: 2023-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1050

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TREATMENT DISCONTINUATION	12 months	A patient will be considered to have discontinued FK adalimumab (not persistent) if the investigator reports a permanent discontinuation or if the patient has been more than 90 consecutive days not covered by treatment (based on the refills reported).