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Clinical Trials/NCT05190484
NCT05190484UnknownNot Applicable

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

Fresenius Kabi0 sites1,050 target enrollmentStarted: April 30, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
1,050
Primary Endpoint
TREATMENT DISCONTINUATION
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

TREATMENT DISCONTINUATION

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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