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Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm)

This study is currently recruiting participants.
Verified September 2016 by Fundación Academia Española de Dermatología
Sponsor:
ClinicalTrials.gov Identifier:
NCT02075697
First Posted: March 3, 2014
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Agencia Española de Medicamentos y Productos Sanitarios
Janssen, LP
Merck Sharp & Dohme Corp.
Pfizer
Abbott
Information provided by (Responsible Party):
Fundación Academia Española de Dermatología
  Purpose
The purpose of Biobadaderm is a to study the safety of systemic therapy in psoriasis.

Condition
Psoriasis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Spanish Registry of Systemic Treatments in Psoriasis

Resource links provided by NLM:


Further study details as provided by Fundación Academia Española de Dermatología:

Primary Outcome Measures:
  • Serious Adverse Events [ Time Frame: an expected mean follow-up of 5 years ]
    Lag windows used to link events and therapy are described in the study web site.


Secondary Outcome Measures:
  • Other adverse events leading to changes in drug therapy or unexpected visits to health provider [ Time Frame: an expected mean follow-up of 5 years ]

Other Outcome Measures:
  • Mortality [ Time Frame: an expected mean follow-up of 5 years ]

Estimated Enrollment: 1887
Study Start Date: October 2008
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Biologic drugs
Drug data include biologic therapy (including infliximab (INF), etanercept (ET), efalizumab (EFA), adalimumab (ADA), and ustekinumab (UTK).
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).

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Psoriasis patients requiring systemic therapy.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075697


Contacts
Contact: Ignacio Garcia-Doval, PhD, MScEpid 34- 915446284 investigacion@aedv.es

Locations
Spain
Hospital Universitari German Trias y Pujol. Recruiting
Badalona, Barcelona, Spain
Fundación Hospital Alcorcón Recruiting
Alcorcón, Madrid, Spain
Hospital General Universitario de Alicante Recruiting
Alicante, Spain
Hospital Clinic Recruiting
Barcelona, Spain
Hospital del Mar. IMAS Recruiting
Barcelona, Spain
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain
Hospital Universitario de Gran Canaria Dr Negrín Recruiting
Las Palmas, Spain
Hospital Infanta Leonor Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Hospital Universitario de la Princesa Recruiting
Madrid, Spain
Hospital Clínico Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Hospital Universitario Virgen Macarena de Sevilla Recruiting
Sevilla, Spain
Hospital General Universitario de Valencia Recruiting
Valencia, Spain
Sponsors and Collaborators
Fundación Academia Española de Dermatología
Agencia Española de Medicamentos y Productos Sanitarios
Janssen, LP
Merck Sharp & Dohme Corp.
Pfizer
Abbott
Investigators
Principal Investigator: Esteban Daudén, PhD Hospital de La Princesa- Madrid
  More Information

Additional Information:
Publications:

Responsible Party: Fundación Academia Española de Dermatología
ClinicalTrials.gov Identifier: NCT02075697     History of Changes
Other Study ID Numbers: Biobadaderm
Biobadaderm ( Registry Identifier: Biobadaderm )
First Submitted: January 3, 2013
First Posted: March 3, 2014
Last Update Posted: December 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fundación Academia Española de Dermatología:
psoriasis
biologic therapy
infliximab
etanercept
efalizumab
adalimumab
ustekinumab
methotrexate
cyclosporine
acitretin

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents