bIosimilar of aDalimumab, an European evAluation

Rheumatoid Arthritis Clinical Trial

— IDEA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05190484
• Other study ID #: ADAL-004-CNI
• Status: Not yet recruiting
• Start date: April 30, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2022
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1050
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TREATMENT DISCONTINUATION	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