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OpenTrials
Completed

NCT Number: NCT04808739

Adalimumab Biosimilar in Clinical Practice

This is an observational, retrospective, multicenter, and descriptive study of patients treated with adalimumab biosimilar for psoriasis, according to clinical practice.

Existing data will be collected from the Dermatology Services database of the hospitals participating in the study, from the medical histories of all treated patients who meet the inclusion criteria and sign informed consent.

The aim of the study is to determine the effectiveness of the different adalimumab biosimilars in clinical practice.

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Key information

Age range

2 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

About this study

Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic treatment. There are currently several biosimilar drugs (Amgevita, Imraldi, Hyrimoz, Idacio, Hulio,…) in addition to the reference product (Humira).

The reduction in the cost of production of biosimilar drugs with respect to reference products has led to their replacement by biosimilar drugs in patients initiating biological therapy, but some centers are also switching to adalimumab biosimilar in patients who are controlled with original adalimumab (Humira).

There are no actual clinical efficacy / safety data in our setting on the use of adalimumab biosimilars.

There is also no evidence of maintenance response in patients who are switched from adalimumab (Humira) to biosimilar adalimumab in clinical practice.

This retrospective study will collect demographic and disease data of the psoriasis patient treated with the different biosimilars of adalimumab, as well as their comorbidities, response to treatment, and safety. In this way, data will be available in usual clinical practice to improve the management of the patient with psoriasis treated with biosimilar drugs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both sexes who have received treatment with adalimumab and who have signed an informed consent.

Exclusion criteria

  • Refusal to participate.
  • Any other cause of exclusion based on clinical criteria and the technical data sheet of the drug.

Treatment and study plan

Adalimumab

Biological

Analysis of survival of adalimumab biosimilar in clinical practice

Primary outcomes

  1. Median time of survival (months) of adalimumab biosimilar in clinical practice

    Time frame: 1 year

    Median time of survival (months) of patients under treatment with adalimumab biosimilar in clinical practice

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Official study title

Retrospective Observational Study to Analyze the Effectiveness of Adalimumab

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2021
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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