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Trial record 26 of 31 for:    ACITRETIN

Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm)

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ClinicalTrials.gov Identifier: NCT02075697
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Spanish Agency of Medicines and Health Products
Janssen, LP
Merck Sharp & Dohme Corp.
Pfizer
Abbott
Eli Lilly and Company
Novartis
Information provided by (Responsible Party):
Fundación Academia Española de Dermatología

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

Condition or disease
Psoriasis

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Spanish Registry of Systemic Treatments in Psoriasis
Study Start Date : October 2008
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort
New drugs
Cohort exposed to biologic therapy, apremilast or fumarates
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).



Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. Mortality [ Time Frame: an expected mean follow-up of 5 years ]


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.


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

Locations
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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
Spanish Agency of Medicines and Health Products
Janssen, LP
Merck Sharp & Dohme Corp.
Pfizer
Abbott
Eli Lilly and Company
Novartis
Investigators
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Principal Investigator: Esteban Daudén, PhD Hospital de La Princesa- Madrid

Additional Information:
Publications of Results:

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Responsible Party: Fundación Academia Española de Dermatología
ClinicalTrials.gov Identifier: NCT02075697     History of Changes
Other Study ID Numbers: Biobadaderm
Biobadaderm ( Registry Identifier: Biobadaderm )
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
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:
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Acitretin
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cyclosporine
Methotrexate
Cyclosporins
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents
Calcineurin Inhibitors
Keratolytic Agents