bIosimilar of aDalimumab, an European evAluation

Brief Title

bIosimilar of aDalimumab, an European evAluation

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

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.
    



Study Type

Observational


Primary Outcome

TREATMENT DISCONTINUATION


Condition

Rheumatoid Arthritis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1050

Start Date

April 30, 2022

Completion Date

April 30, 2024

Primary Completion Date

April 30, 2023

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT05190484

Organization ID

ADAL-004-CNI


Responsible Party

Sponsor

Study Sponsor

Fresenius Kabi


Study Sponsor

, , 


Verification Date

January 2022