Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Fundación Academia Española de Dermatología
Sponsor:
Collaborators:
Spain: Spanish Agency of Medicines
Janssen, LP
Merck Sharp & Dohme Corp.
Pfizer
Abbott
Information provided by (Responsible Party):
Fundación Academia Española de Dermatología
ClinicalTrials.gov Identifier:
NCT02075697
First received: January 3, 2013
Last updated: February 28, 2014
Last verified: February 2014
  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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Mortality [ Time Frame: an expected mean follow-up of 5 years ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 del Mar. IMAS Recruiting
Barcelona, Spain
Hospital Clinic Recruiting
Barcelona, Spain
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain
Hospital Universitario de Gran Canaria Dr Negrín Recruiting
Las Palmas, Spain
Hospital Universitario de la Princesa Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Hospital Infanta Leonor 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
Spain: Spanish Agency of Medicines
Janssen, LP
Merck Sharp & Dohme Corp.
Pfizer
Abbott
Investigators
Principal Investigator: Francisco Vanaclocha, PhD Hospital 12 de Octubre- 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
Study First Received: January 3, 2013
Last Updated: February 28, 2014
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on August 19, 2014