bIosimilar of aDalimumab, an European evAluation

NCT ID: NCT05190484

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1050 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2024-04-30

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ADAL-004-CNI

Identifier Type: -

Identifier Source: org_study_id