Spanish Registry of Systemic Treatments in Psoriasis

Psoriasis Clinical Trial

— Biobadaderm  

Official title:

Spanish Registry of Systemic Treatments in Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02075697
• Other study ID #: Biobadaderm
• Secondary ID: Biobadaderm
• Status: Recruiting
• Start date: October 2008
• Est. completion date: October 2025

Study information

• Verified date: March 2022
• Source: Fundación Academia Española de Dermatología
• Contact: Ignacio Garcia-Doval, PhD, MScEpid
• Phone: 34- 915446284
• Email: investigacion[@]aedv.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Spain	Fundación Hospital Alcorcón	Alcorcón	Madrid
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitari German Trias y Pujol.	Badalona	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital del Mar. IMAS	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario de Gran Canaria Dr Negrín	Las Palmas
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Clínico Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario Virgen Macarena de Sevilla	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia

Sponsors (14)

Lead Sponsor	Collaborator
Fundación Academia Española de Dermatología	AbbVie, Almirall, SAS, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, Janssen, LP, LEO Pharma, Merck Sharp & Dohme Corp., Novartis, Pfizer, Spanish Agency of Medicines and Health Products, UCB Pharma

Country where clinical trial is conducted

Spain, 

References & Publications (27)

Belinchón I, Ramos JM, Carretero G, Ferrándiz C, Rivera R, Daudén E, De la Cueva-Dobao P, Gómez-García FJ, Herrera-Ceballos E, Sánchez-Carazo JL, López-Estebaranz JL, Alsina M, Ferrán M, Torrado R, Carrascosa JM, Llamas-Velasco M, Ortiz PL, García-Doval I — View Citation

Carrascosa JM, Garcia-Doval I, Pérez-Zafrilla B, Carretero G, Vanaclocha F, Daudén E, De la Cueva-Dobao P, Belinchón I, Alsina M, López-Estebaranz JL, Ferrán M, Torrado R, Rivera R, Carazo C, Barboza L, Ferrándiz C; BIOBADADERM Study Group. Use of off-lab — View Citation

Carrascosa JM, Rivera N, Garcia-Doval I, Carretero G, Vanaclocha F, Daudén E, Gómez-García FJ, De-la-Cueva-Dobao P, Herrera-Ceballos E, Belinchón I, Alsina M, Sánchez-Carazo JL, Ferrán M, Lopez-Estebaranz JL, Pérez-Zafrilla B, Llamas M, Rivera R, Ferrándi — View Citation

Carrascosa JM, Vilavella M, Garcia-Doval I, Carretero G, Vanaclocha F, Daudén E, Gómez-García FJ, Herrera-Ceballos E, De la Cueva Dobao P, Belinchón I, Sánchez-Carazo JL, Alsina M, López-Estebaranz JL, Ferrán M, Peral F, Torrado R, Rivera R, Jiménez-Puya — View Citation

Carretero G, Ferrandiz C, Dauden E, Vanaclocha Sebastián F, Gómez-García FJ, Herrera-Ceballos E, De la Cueva-Dobao P, Belinchón I, Sánchez-Carazo JL, Alsina-Gibert M, López-Estebaranz JL, Ferrán M, Torrado R, Carrascosa JM, Carazo C, Rivera R, Jiménez-Puy — View Citation

Carretero Hernández G, Ferrándiz C, Rivera Díaz R, Daudén Tello E, de la Cueva-Dobao P, Gómez-García FJ, Herrera-Ceballos E, Belinchón Romero I, López-Estebaranz JL, Alsina Gibert M, Sánchez-Carazo JL, Ferrán Farrés M, González Quesada A, Carrascosa Carri — View Citation

Dávila-Seijo P, Dauden E, Carretero G, Ferrandiz C, Vanaclocha F, Gómez-García FJ, Herrera-Ceballos E, De la Cueva-Dobao P, Belinchón I, Sánchez-Carazo JL, Alsina M, López-Estebaranz JL, Ferrán M, Torrado R, Carrascosa JM, Llamas M, Rivera R, Jiménez-Puya — View Citation

Dávila-Seijo P, Dauden E, Descalzo MA, Carretero G, Carrascosa JM, Vanaclocha F, Gómez-García FJ, De la Cueva-Dobao P, Herrera-Ceballos E, Belinchón I, López-Estebaranz JL, Alsina M, Sánchez-Carazo JL, Ferrán M, Torrado R, Ferrandiz C, Rivera R, Llamas M, — View Citation

Davila-Seijo P, Garcia-Doval I, Naldi L, Cazzaniga S, Augustin M, Rustenbach SJ, Daudén E, Dam TN, Baker C, Spuls PI, Stern RS, Cohen AD. Factors Associated with Receiving Biologics or Classic Systemic Therapy for Moderate-to-Severe Psoriasis: Evidence fr — View Citation

Descalzo MA, Carretero G, Ferrándiz C, Rivera R, Daudén E, Gómez-García FJ, de la Cueva P, Herrera-Ceballos E, Belinchón I, López-Estebaranz JL, Alsina M, Sánchez-Carazo JL, Ferrán M, Baniandrés O, Carrascosa JM, Llamas-Velasco M, Ruiz-Genao D, Herrera-Ac — View Citation

Echeverría-García B, Nuño-González A, Dauden E, Vanaclocha F, Torrado R, Belinchón I, Pérez-Zafrilla B; Grupo de estudio BIOBADADERM. A Case Series of Patients With Psoriasis Exposed to Biologic Therapy During Pregnancy: The BIOBADADERM Register and a Rev — View Citation

Galiano Mejías S, Carretero G, Ferrandiz C, Vanaclocha F, Daudén E, Gómez-García FJ, Herrera-Ceballos E, Belinchón-Romero I, Sánchez-Carazo JL, López-Estebaranz JL, Alsina M, Ferrán M, Torrado R, Carrascosa JM, Rivera R, Llamas-Velasco M, Jiménez-Puya R, — View Citation

Garcia-Doval I, Carretero G, Vanaclocha F, Ferrandiz C, Daudén E, Sánchez-Carazo JL, Alsina M, Herrera-Ceballos E, Gómez-García FJ, Ferrán M, López-Estebaranz JL, Hernanz JM, Belinchón-Romero I, Vilar-Alejo J, Rivera R, Carrascosa JM, Carazo C. Risk of se — View Citation

Garcia-Doval I, Cohen AD, Cazzaniga S, Feldhamer I, Addis A, Carretero G, Ferrándiz C, Stern RS, Naldi L; Psonet Network. Risk of serious infections, cutaneous bacterial infections, and granulomatous infections in patients with psoriasis treated with anti — View Citation

Garcia-Doval I, Descalzo MA, Mason KJ, Cohen AD, Ormerod AD, Gómez-García FJ, Cazzaniga S, Feldhamer I, Ali H, Herrera-Acosta E, Griffiths CEM, Stern RS, Naldi L; Psonet Network. Cumulative exposure to biological therapy and risk of cancer in patients wit — View Citation

García-Doval I, Hernández MV, Vanaclocha F, Sellas A, de la Cueva P, Montero D; BIOBADADERM and BIOBADASER study groups. Should tumour necrosis factor antagonist safety information be applied from patients with rheumatoid arthritis to psoriasis? Rates of — View Citation

García-Doval I, Pérez-Zafrilla B, Ferrandiz C, Carretero G, Daudén E, de la Cueva P, Gómez-García FJ, Herrera-Ceballos E, Belinchón-Romero I, Sánchez-Carazo JL, López-Estebaranz JL, Alsina M, Ferrán M, Torrado R, Carrascosa JM, Rivera R, Vanaclocha F; BIO — View Citation

Garcia-Doval I, Rustenbach SJ, Stern R, Dam TN, Cohen AD, Baker C, Spuls PI, Naldi L; Psonet Network. Systemic psoriasis therapy shows high between-country variation: a sign of unwarranted variation? Cross-sectional analysis of baseline data from the PSON — View Citation

Gonzalez-Cantero A, Carretero G, Rivera R, Ferrándiz C, Daudén E, de la Cueva P, Gómez-García FJ, Belinchón I, Herrera-Ceballos E, Ruiz-Genao D, Ferrán M, Alsina M, Sánchez-Carazo JL, Baniandrés O, Sahuquillo-Torralba A, Rodriguez L, Vilar J, García C, Ca — View Citation

Medina C, Carretero G, Ferrandiz C, Dauden E, Vanaclocha F, Gómez-García FJ, Herrera-Ceballos E, De la Cueva-Dobao P, Belinchón I, Sánchez-Carazo JL, Alsina M, López-Estebaranz JL, Ferrán M, Carrascosa JM, Torrado R, Argila D, Rivera R, Jiménez-Puya R, Ga — View Citation

Montes-Torres A, Aparicio G, Rivera R, Vilarrasa E, Marcellán M, Notario J, Soria C, Belinchón I, de la Cueva P, Ferrán M, Carrascosa JM, Gómez FJ, Salgado L, Velasco M, Descalzo MÁ, García-Doval I, Daudén E; ; the BIOBADADERM Study Group and Psoriasis Gr — View Citation

Pérez-Plaza A, Carretero G, Ferrandiz C, Vanaclocha F, Gómez-García FJ, Herrera-Ceballos E, De la Cueva-Dobao P, Belinchón I, Sánchez-Carazo JL, Alsina M, López-Estebaranz JL, Ferrán M, Torrado R, Carrascosa JM, Llamas-Velasco M, Rivera R, Jiménez-Puya R, — View Citation

Rivera R, García-Doval I, Carretero G, Daudén E, Sánchez-Carazo J, Ferrándiz C, Herrera E, Alsina M, Ferrán M, López-Estebaranz JL, Gómez F, Herranz JM, Carrascosa JM, Vanaclocha F; miembros del grupo BIOBADADERM. [BIOBADADERM, the Spanish Registry of Adv — View Citation

Ruiz-Genao D, Perez-Zafrilla B, Lopez-Estebaranz JL, Belinchón-Romero I, Carrascosa JM, Ferrán M, Vanaclocha F, Herrera-Ceballos E, García-Doval I; Biobadaderm Study Group. Possible paradoxical occurrence of inflammatory arthritis in patients with psorias — View Citation

Sahuquillo-Torralba A, Carretero G, Rivera R, Ferrándiz C, Daudén-Tello E, de la Cueva P, Gómez-García FJ, Belinchón I, Herrera-Acosta E, Ruiz-Genao D, Ferrán M, Alsina M, Sánchez-Carazo JL, Baniandrés O, Fernández-Freire LR, Vilar J, García-Donoso C, Car — View Citation

Sánchez-Moya AI, García-Doval I, Carretero G, Sánchez-Carazo J, Ferrandiz C, Herrera Ceballos E, Alsina M, Ferrán M, López-Estebaranz JL, Gómez-García F, De la Cueva Dobao P, Carrascosa JM, Vanaclocha F, Belinchón I, Peral F, Dauden E; BIOBADADERM Study G — View Citation

Sanz-Bueno J, Vanaclocha F, García-Doval I, Torrado R, Carretero G, Daudén E, Patricia Ruiz-Genao D, Alsina-Gibert MM, Pérez-Zafrilla B, Pérez-Rial G, Rivera R; members of the BIOBADADERM group. Risk of Reactivation of Hepatitis B Virus Infection in Psori — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Rate	an expected mean follow-up of 5 years
Primary	Serious Adverse Events	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	Other adverse events leading to changes in drug therapy or unexpected visits to health provider	Rate	an expected mean follow-up of 5 years

External Links

•   List of Biobadaderm publications