Study identification

PURI

https://redirect.ema.europa.eu/resource/7608

EU PAS number

EUPAS7607

Study ID

7608

Official title and acronym

Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm)

DARWIN EU® study

No

Study countries

Spain

Study description

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), andIdentify risk factors for AEs in patients with these treatments.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).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.

Study status

Ongoing
Research institution and networks

Institutions

Research Unit
Research Unit. Fundación AEDV Madrid, Spain, Hospital Universitario de la Princesa Madrid, Spain, Hospital Universitario de Gran Canaria Dr Negrín Las Palmas, Spain, Hospital Universitari German Trias y Pujol. Badalona, Barcelona, Spain, Hospital Universitario 12 de Octubre Madrid, Spain, Hospital Clinic Barcelona, Spain, Fundación Hospital Alcorcón Alcorcón, Madrid, Spain, Hospital Universitario Reina Sofía Córdoba, Spain, Hospital del Mar. IMAS Barcelona, Spain, Hospital General Universitario de Alicante Alicante, Spain

Networks

European Registry of Psoriasis (Psonet)
Austria
Czechia
Denmark
France
Germany
Italy
Lithuania
Netherlands
Portugal
Romania
Slovenia
Spain
Sweden
Switzerland
United Kingdom
First published:
08/08/2018
Network
ENCePP partner

Contact details

Ignacio Garcia-Doval

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Other

More details on funding

Abbvie, Janssen, MSD, Novartis, Pfizer, Agencia Española del Medicamento y Productos Sanitarios (AEMPS)
Study protocol
Initial protocol

5 Protocolo Biobadaderm V7.1-2011

English (381.38 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No