Clinical trial NCT02075697: Spanish Registry of Systemic Treatments in Psoriasis
Official title: Spanish Registry of Systemic Treatments in Psoriasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Keywords: psoriasis
biologic therapy
infliximab
etanercept
efalizumab
adalimumab
ustekinumab
methotrexate
cyclosporine
acitretin
Lead sponsor: Fundación Academia Española de Dermatología
Sponsor class: OTHER
Collaborators: name: Spanish Agency of Medicines and Health Products
name: Janssen, LP
name: Merck Sharp & Dohme LLC
name: Pfizer
name: AbbVie
name: Eli Lilly and Company
name: Novartis
name: Boehringer Ingelheim
name: Bristol-Myers Squibb
name: UCB Pharma
name: Almirall, SAS
name: Amgen
name: LEO Pharma
First posted: 2014-03-03
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Psoriasis patients requiring systemic therapy.

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

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).

Eligibility 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

Primary outcomes:
measure: Serious Adverse Events
timeFrame: an expected mean follow-up of 5 years
Secondary outcomes:
measure: Other adverse events leading to changes in drug therapy or unexpected visits to health provider
timeFrame: an expected mean follow-up of 5 years
Other outcomes:
measure: Mortality
timeFrame: an expected mean follow-up of 5 years
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari German Trias y Pujol.
state: Barcelona
city: Alcorcón
country: Spain
facility: Fundación Hospital Alcorcón
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital del Mar. IMAS
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Dr Negrín
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Málaga
country: Spain
facility: Hospital Clínico Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena de Sevilla
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
affiliation: Hospital de La Princesa- Madrid
name: Esteban Daudén, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Galiano Mejias S, Carretero G, Ferrandiz C, Vanaclocha F, Dauden E, Gomez-Garcia FJ, Herrera-Ceballos E, Belinchon-Romero I, Sanchez-Carazo JL, Lopez-Estebaranz JL, Alsina M, Ferran M, Torrado R, Carrascosa JM, Rivera R, Llamas-Velasco M, Jimenez-Puya R, Mendiola MV, Ruiz-Genao D, Descalzo MA, de la Cueva Dobao P; del grupo Biobadaderm. Management of Biologic Therapy in Moderate to Severe Psoriasis in Surgical Patients: Data From the Spanish Biobadaderm Registry. Actas Dermosifiliogr. 2017 Jan-Feb;108(1):52-58. doi: 10.1016/j.ad.2016.08.003. Epub 2016 Sep 20. English, Spanish.