Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm)

March 15, 2022 updated by: Fundación Academia Española de Dermatología
The purpose of Biobadaderm is a to study the safety of systemic therapy in psoriasis.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The Spanish Registry for Adverse Events of Biological Therapies in Dermatology (BIOBADADERM) was launched in October 2008, as a pharmacovigilance effort for psoriatic patients. The registry is managed by the Foundation of the Spanish Academy of Dermatology and Venereology (AEDV). BIOBADADERM has been promoted by the AEDV, in collaboration with the Spanish Agency for Medicines and Health Products (AEMPS) and the Research Unit of the Spanish Foundation of Rheumatology (FER) and the Research Unit of the Fundacion AEDV. BIOBADADERM is part of PSONET, a European network for sharing data from records of patients treated with biologics.

BIOBADADERM is a prospective cohort of patients receiving biologic drugs that can be compared with another cohort of patients receiving other systemic treatments. One of the cohorts is made up of all consecutive psoriasis patients who begin any biological therapy (including infliximab (INF), etanercept (ET), efalizumab (EFA), adalimumab (ADA), rituximab (RTX) and ustekinumab (UTK)) in each centre. The control cohort consists of psoriasis patients who begin, for the first time, a nonbiologic systemic treatment (methotrexate, cyclosporine or acitretin).

The objectives of BIOBADADERM are:

  • Identify adverse events (AEs) occurring during the relevant treatment with biologic therapies, and estimate their frequency;
  • Identify unexpected AEs, particularly those that may occur after long periods of exposure;
  • Identify relevant AEs that arise after discontinuation of treatment;
  • Estimate the relative risk of developing AEs with biologic therapies in patients with psoriasis compared to psoriatic patients exposed to other systemic (non-biological); and
  • Identify risk factors for AEs in patients with these treatments.

Data were initially collected retrospectively in hospitals with a list of all patients who had received biologic drugs between 1 January 2005 and 30 October 2008 and check-ups with a frequency of at least every 6 months. Since 2008, data have been captured prospectively.

The database includes demographic, diagnostic and comorbidity data, the treatments performed, the duration of these treatments and the adverse effects that arise (coded using MedDRA). In its first year, 632 patients from 12 centers participated with BIOBADADERM. In October 2012 the registry had data from 1,793 patients, which includes 946 patients on biologic treatments and 847 patients on non-biologic systemic treatments.

Data for each patient have been reversibly anonymized and entered into a database. Data are entered over the Internet (http://biobadaser.ser.es/biobadaderm/). The data are stored in the Research Department of the Spanish Rheumatology Foundation.

The included data are continually revised online by a study monitor to verify consistency, comprehensiveness, and absence of anomalies. A follow-up visit is made every year during which a sample of the the data in the database are compared with those in the clinical records.

Sample size was calculated to give, after 5 years, 80% power and using alfa level= 0.05, to detect a rate ratio of 2 in events with 4.1 cases per 1000 person-years, or a rate ratio of 5 in events with 0.5 cases per 1000 person-years. Further calculations are available in the study protocol (https://biobadaser.ser.es/biobadaderm/index.html).

Default value in each variable is "missing". Plans for missing data in analysis depend on the aim of analysis but with a preference for the most conservative ( in terms of patient safety) analysis.

Analysis consists of description of rates, rate ratios and adjusted rate ratios (adjusted for possible confounders, age always included).

Study Type

Observational

Enrollment (Anticipated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario de Alicante
      • Barcelona, Spain
        • Recruiting
        • Hospital Clínic
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar. IMAS
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofía
      • Las Palmas, Spain
        • Recruiting
        • Hospital Universitario de Gran Canaria Dr Negrin
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de octubre
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario de La Princesa
      • Madrid, Spain
        • Recruiting
        • Hospital Infanta Leonor
      • Málaga, Spain
        • Recruiting
        • Hospital Clinico Universitario Virgen de la Victoria
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen Macarena de Sevilla
      • Valencia, Spain
        • Recruiting
        • Hospital General Universitario de Valencia
    • Barcelona
      • Badalona, Barcelona, Spain
        • Recruiting
        • Hospital Universitari German Trias y Pujol.
    • Madrid
      • Alcorcón, Madrid, Spain
        • Recruiting
        • Fundación Hospital Alcorcón

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Psoriasis patients requiring systemic therapy.

Description

Inclusion Criteria:

  • For biologics group: all consecutive psoriasis patients who begin any biological therapy
  • For classic systemic group: the next psoriasis patients who begin, for the first time, a nonbiologic systemic treatment (after including a patient in the biologics group)

Exclusion Criteria:

  • Intention of moving to a different geographic area in the next three 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

Cohorts and Interventions

Group / Cohort
New drugs
Cohort exposed to biologic therapy, apremilast or fumarates
Classic systemic therapy
Non-biological systemic treatment (methotrexate, cyclosporine and acitretin) Phototherapy was accepted as systemic therapy only in the small group of patients retrospectively included(PUVA, UVB 311).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events
Time Frame: an expected mean follow-up of 5 years
Rates and trate ratio compared to other drugs. Lag windows used to link events and therapy are described in the study web site.
an expected mean follow-up of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other adverse events leading to changes in drug therapy or unexpected visits to health provider
Time Frame: an expected mean follow-up of 5 years
Rate
an expected mean follow-up of 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: an expected mean follow-up of 5 years
Rate
an expected mean follow-up of 5 years

Collaborators and Investigators

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

Sponsor

Fundación Academia Española de Dermatología

Collaborators

Bristol-Myers Squibb
Eli Lilly and Company
UCB Pharma
Merck Sharp & Dohme LLC
Novartis
Pfizer
AbbVie
Boehringer Ingelheim
LEO Pharma
Amgen
Janssen, LP
Spanish Agency of Medicines and Health Products
Almirall, SAS

Investigators

  • Principal Investigator: Esteban Daudén, PhD, Hospital de La Princesa- Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

October 1, 2008

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biobadaderm (Registry Identifier: Biobadaderm)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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