bIosimilar of aDalimumab, an European evAluation (IDEA)

January 4, 2022 updated by: Fresenius Kabi

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

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include male and female adult patients with an IMID who were prescribed FK adalimumab, meet all the study inclusion criteria and none of the exclusion criteria and provide written informed consent to participate.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2022

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADAL-004-CNI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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