bIosimilar of aDalimumab, an European evAluation

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05190484

Acronym

IDEA

Enrollment

1050

Registered

2022-01-13

Start date

2022-04-30

Completion date

2024-04-30

Last updated

2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

adalimumab, biosimilar

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
TREATMENT DISCONTINUATION	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).

Outcome results