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PsoriasisBiobadadermNCT02075697

Spanish Registry of Systemic Treatments in Psoriasis

An observational study of Psoriasis, run by Fundación Academia Española de Dermatología at 13 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of Biobadaderm is a to study the safety of systemic therapy in psoriasis. Read more about this study

Who is it for?
Any age
Conditions the study is for
Psoriasis
How many people
3,500 participants
Where
13 sitesSpain
Study dates
Oct 2008to Oct 2025
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Psoriasis patients requiring systemic therapy.

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

Ignacio Garcia-Doval, PhD, MScEpid contact

34- 915446284

investigacion@aedv.es

13 sites in 1 country

Spain13 sites, 13 recruiting

  • Fundación Hospital Alcorcón

    Alcorcón, Madrid

    Recruiting

  • Hospital General Universitario de Alicante

    Alicante

    Recruiting

  • Hospital Universitari German Trias y Pujol.

    Badalona, Barcelona

    Recruiting

  • Hospital Clinic

    Barcelona

    Recruiting

  • Hospital del Mar. IMAS

    Barcelona

    Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba

    Recruiting

  • Hospital Universitario de Gran Canaria Dr Negrín

    Las Palmas

    Recruiting

  • Hospital Infanta Leonor

    Madrid

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Recruiting

  • Hospital Universitario de la Princesa

    Madrid

    Recruiting

  • Hospital Clínico Universitario Virgen de la Victoria

    Málaga

    Recruiting

  • Hospital Universitario Virgen Macarena de Sevilla

    Seville

    Recruiting

  • Hospital General Universitario de Valencia

    Valencia

    Recruiting

Other trials in Spain

About this study

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

Read the 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).

Conditions
Psoriasis
Keywords
psoriasis, biologic therapy, infliximab, etanercept, efalizumab, adalimumab, ustekinumab, methotrexate, cyclosporine, acitretin
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02075697
Study groupRoleWhat they receive
New drugsCohort exposed to biologic therapy, apremilast or fumarates
Classic systemic therapyNon-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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: an expected mean follow-up of 5 years

Secondary outcomes (1)

  1. Other adverse events leading to changes in drug therapy or unexpected visits to health provider

    Rate

    Measured: an expected mean follow-up of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study startOct 2008
  3. Primary completionOct 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02075697
Sponsor's protocol ID
Biobadaderm
Other IDs
Biobadaderm
Acronym
Biobadaderm
Status last verified
Mar 2022
First submitted
3 Jan 2013
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Rivera R, Garcia-Doval I, Carretero G, Dauden E, Sanchez-Carazo J, Ferrandiz C, Herrera E, Alsina M, Ferran M, Lopez-Estebaranz JL, Gomez F, Herranz JM, Carrascosa JM, Vanaclocha F; miembros del grupo BIOBADADERM. [BIOBADADERM, the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology: first report]. Actas Dermosifiliogr. 2011 Mar;102(2):132-41. doi: 10.1016/j.ad.2010.10.016. Epub 2011 Mar 4. Spanish.

    PubMed 21377137

  • Garcia-Doval I, Carretero G, Vanaclocha F, Ferrandiz C, Dauden E, Sanchez-Carazo JL, Alsina M, Herrera-Ceballos E, Gomez-Garcia FJ, Ferran M, Lopez-Estebaranz JL, Hernanz JM, Belinchon-Romero I, Vilar-Alejo J, Rivera R, Carrascosa JM, Carazo C. Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients ineligible vs eligible for randomized controlled trials. Arch Dermatol. 2012 Apr;148(4):463-70. doi: 10.1001/archdermatol.2011.2768.

    PubMed 22508869

  • Sanchez-Moya AI, Garcia-Doval I, Carretero G, Sanchez-Carazo J, Ferrandiz C, Herrera Ceballos E, Alsina M, Ferran M, Lopez-Estebaranz JL, Gomez-Garcia F, De la Cueva Dobao P, Carrascosa JM, Vanaclocha F, Belinchon I, Peral F, Dauden E; BIOBADADERM Study Group. Latent tuberculosis infection and active tuberculosis in patients with psoriasis: a study on the incidence of tuberculosis and the prevalence of latent tuberculosis disease in patients with moderate-severe psoriasis in Spain. BIOBADADERM registry. J Eur Acad Dermatol Venereol. 2013 Nov;27(11):1366-74. doi: 10.1111/jdv.12011. Epub 2012 Nov 8.

    PubMed 23134268

  • Carrascosa JM, Vilavella M, Garcia-Doval I, Carretero G, Vanaclocha F, Dauden E, Gomez-Garcia FJ, Herrera-Ceballos E, De la Cueva Dobao P, Belinchon I, Sanchez-Carazo JL, Alsina M, Lopez-Estebaranz JL, Ferran M, Peral F, Torrado R, Rivera R, Jimenez-Puya R, Mendiola MV, Ferrandiz C; BIOBADADERM Study Group. Body mass index in patients with moderate-to-severe psoriasis in Spain and its impact as an independent risk factor for therapy withdrawal: results of the Biobadaderm Registry. J Eur Acad Dermatol Venereol. 2014 Jul;28(7):907-14. doi: 10.1111/jdv.12208. Epub 2013 Jul 15.

    PubMed 23848131

  • 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 PSONET registries. Br J Dermatol. 2013 Sep;169(3):710-4. doi: 10.1111/bjd.12344. No abstract available.

    PubMed 23551034

  • Medina C, Carretero G, Ferrandiz C, Dauden E, Vanaclocha F, Gomez-Garcia FJ, Herrera-Ceballos E, De la Cueva-Dobao P, Belinchon I, Sanchez-Carazo JL, Alsina M, Lopez-Estebaranz JL, Ferran M, Carrascosa JM, Torrado R, Argila D, Rivera R, Jimenez-Puya R, Garcia-Doval I; BIOBADADERM Study Group. Safety of classic and biologic systemic therapies for the treatment of psoriasis in elderly: an observational study from national BIOBADADERM registry. J Eur Acad Dermatol Venereol. 2015 May;29(5):858-64. doi: 10.1111/jdv.12688. Epub 2014 Sep 3.

    PubMed 25185962

  • Carretero G, Ferrandiz C, Dauden E, Vanaclocha Sebastian F, Gomez-Garcia FJ, Herrera-Ceballos E, De la Cueva-Dobao P, Belinchon I, Sanchez-Carazo JL, Alsina-Gibert M, Lopez-Estebaranz JL, Ferran M, Torrado R, Carrascosa JM, Carazo C, Rivera R, Jimenez-Puya R, Garcia-Doval I; BIOBADADERM Study Group. Risk of adverse events in psoriasis patients receiving classic systemic drugs and biologics in a 5-year observational study of clinical practice: 2008-2013 results of the Biobadaderm registry. J Eur Acad Dermatol Venereol. 2015 Jan;29(1):156-63. doi: 10.1111/jdv.12492. Epub 2014 Mar 31.

    PubMed 24684267

  • Garcia-Doval I, Perez-Zafrilla B, Ferrandiz C, Carretero G, Dauden E, de la Cueva P, 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, Vanaclocha F; BIOBADADERM Study Group. Development of clinical prediction models for good or bad response to classic systemic drugs, anti-TNFs, and ustekinumab in psoriasis, based on the BIOBADADERM cohort. J Dermatolog Treat. 2016;27(3):203-9. doi: 10.3109/09546634.2015.1088130. Epub 2015 Sep 25.

    PubMed 26367799

  • Sanz-Bueno J, Vanaclocha F, Garcia-Doval I, Torrado R, Carretero G, Dauden E, Patricia Ruiz-Genao D, Alsina-Gibert MM, Perez-Zafrilla B, Perez-Rial G, Rivera R; members of the BIOBADADERM group. Risk of Reactivation of Hepatitis B Virus Infection in Psoriasis Patients Treated With Biologics: A Retrospective Analysis of 20 Cases From the BIOBADADERM Database. Actas Dermosifiliogr. 2015 Jul-Aug;106(6):477-82. doi: 10.1016/j.ad.2015.01.010. Epub 2015 Mar 13. English, Spanish.

    PubMed 25776200

  • Carrascosa JM, Garcia-Doval I, Perez-Zafrilla B, Carretero G, Vanaclocha F, Dauden E, De la Cueva-Dobao P, Belinchon I, Alsina M, Lopez-Estebaranz JL, Ferran M, Torrado R, Rivera R, Carazo C, Barboza L, Ferrandiz C; BIOBADADERM Study Group. Use of off-label doses is frequent in biologic therapy for moderate to severe psoriasis: A cross-sectional study in clinical practice. J Dermatolog Treat. 2015;26(6):502-6. doi: 10.3109/09546634.2015.1034070. Epub 2015 Apr 17.

    PubMed 25886087

  • Carrascosa JM, Rivera N, Garcia-Doval I, Carretero G, Vanaclocha F, Dauden E, Gomez-Garcia FJ, De-la-Cueva-Dobao P, Herrera-Ceballos E, Belinchon I, Alsina M, Sanchez-Carazo JL, Ferran M, Lopez-Estebaranz JL, Perez-Zafrilla B, Llamas M, Rivera R, Ferrandiz C; BIOBADADERM Study Group. Does the treatment ladder for systemic therapy in moderate to severe psoriasis only go up? The percentage of patients with severe psoriasis on biologics increases over time. Actas Dermosifiliogr. 2015 Oct;106(8):638-43. doi: 10.1016/j.ad.2015.04.013. Epub 2015 Jun 30. English, Spanish.

    PubMed 26141003

  • Ruiz-Genao D, Perez-Zafrilla B, Lopez-Estebaranz JL, Belinchon-Romero I, Carrascosa JM, Ferran M, Vanaclocha F, Herrera-Ceballos E, Garcia-Doval I; Biobadaderm Study Group. Possible paradoxical occurrence of inflammatory arthritis in patients with psoriasis treated with biologics: findings in the Biobadaderm cohort. Br J Dermatol. 2017 Mar;176(3):797-799. doi: 10.1111/bjd.14690. Epub 2016 Oct 17. No abstract available.

    PubMed 27120993

  • Garcia-Doval I, Hernandez 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 serious adverse events in the prospective rheumatoid arthritis BIOBADASER and psoriasis BIOBADADERM cohorts. Br J Dermatol. 2017 Mar;176(3):643-649. doi: 10.1111/bjd.14776. Epub 2016 Oct 3.

    PubMed 27258623

  • Davila-Seijo P, Dauden E, Carretero G, Ferrandiz C, Vanaclocha F, Gomez-Garcia FJ, Herrera-Ceballos E, De la Cueva-Dobao P, Belinchon I, Sanchez-Carazo JL, Alsina M, Lopez-Estebaranz JL, Ferran M, Torrado R, Carrascosa JM, Llamas M, Rivera R, Jimenez-Puya R, Garcia-Doval I; BIOBADADERM Study Group. Survival of classic and biological systemic drugs in psoriasis: results of the BIOBADADERM registry and critical analysis. J Eur Acad Dermatol Venereol. 2016 Nov;30(11):1942-1950. doi: 10.1111/jdv.13682. Epub 2016 Jun 22.

    PubMed 27329511

  • Davila-Seijo P, Dauden E, Descalzo MA, Carretero G, Carrascosa JM, Vanaclocha F, Gomez-Garcia FJ, De la Cueva-Dobao P, Herrera-Ceballos E, Belinchon I, Lopez-Estebaranz JL, Alsina M, Sanchez-Carazo JL, Ferran M, Torrado R, Ferrandiz C, Rivera R, Llamas M, Jimenez-Puya R, Garcia-Doval I; BIOBADADERM Study Group. Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry. J Invest Dermatol. 2017 Feb;137(2):313-321. doi: 10.1016/j.jid.2016.08.034. Epub 2016 Sep 25.

    PubMed 27677836

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis, run by Fundación Academia Española de Dermatología at 13 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ignacio Garcia-Doval, PhD, MScEpid (34- 915446284, investigacion@aedv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Events (time frame: an expected mean follow-up of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02075697, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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