IDEA: bIosimilar of aDalimumab, an European evAluation

Sponsor

Fresenius Kabi (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05190484

Collaborator

(none)

1,050

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Crohn Disease Ulcerative Colitis

Study Design

Study Type:

Observational

Anticipated Enrollment :

1050 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 30, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2024

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.