For Healthcare Professionals

bIosimilar of aDalimumab, an European evAluation

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

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

Age

18+

Participants needed

1050

Est. Completion Date

Apr 2024

Treatment type

Observational


Sponsor

Fresenius Kabi

ClinicalTrials.gov identifier

NCT05190484

Study number

ADAL-004-CNI

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