Spanish Registry of Systemic Treatments in Psoriasis

Study Purpose

The purpose of Biobadaderm is a to study the safety of systemic therapy in psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02075697
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fundación Academia Española de Dermatología
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Esteban Daudén, PhD
Principal Investigator Affiliation Hospital de La Princesa- Madrid
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherIndustryIndustryIndustryIndustryIndustryIndustry
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Additional Details

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).

Arms & Interventions

Arms

: 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).

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Badalona, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari German Trias y Pujol.

Badalona, Barcelona,

Fundación Hospital Alcorcón, Alcorcón, Madrid, Spain

Status

Recruiting

Address

Fundación Hospital Alcorcón

Alcorcón, Madrid,

Alicante, Spain

Status

Recruiting

Address

Hospital General Universitario de Alicante

Alicante, ,

Hospital Clinic, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic

Barcelona, ,

Hospital del Mar. IMAS, Barcelona, Spain

Status

Recruiting

Address

Hospital del Mar. IMAS

Barcelona, ,

Hospital Universitario Reina Sofía, Córdoba, Spain

Status

Recruiting

Address

Hospital Universitario Reina Sofía

Córdoba, ,

Las Palmas, Spain

Status

Recruiting

Address

Hospital Universitario de Gran Canaria Dr Negrín

Las Palmas, ,

Hospital Infanta Leonor, Madrid, Spain

Status

Recruiting

Address

Hospital Infanta Leonor

Madrid, ,

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, ,

Hospital Universitario de la Princesa, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de la Princesa

Madrid, ,

Málaga, Spain

Status

Recruiting

Address

Hospital Clínico Universitario Virgen de la Victoria

Málaga, ,

Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen Macarena de Sevilla

Sevilla, ,

Valencia, Spain

Status

Recruiting

Address

Hospital General Universitario de Valencia

Valencia, ,

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