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Multicentric Cohort of Patients Receiving Systemic Treatment (Conventional or Biotherapy) for Moderate to Severe Cutaneous Psoriasis

France, 2012 - 2020
Reference ID
FRESH-PEF8863-en
Producer(s)
Olivier;CHOSIDOW, Florence;TUBACH
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Feb 18, 2026
Last modified
Feb 18, 2026
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  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FRESH-PEF8863-en

    Title

    Multicentric Cohort of Patients Receiving Systemic Treatment (Conventional or Biotherapy) for Moderate to Severe Cutaneous Psoriasis

    Abbreviation or Acronym

    PSOBIOTEQ

    Country
    Name Country code
    France fr
    Kind of Data

    ['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Behavioral data']

    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Oncology health theme
    Dermatology health theme
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant
    Keywords
    systemic conventional treatment methotrexate cyclosporine health safety real life skin cancer carcinoma usage biotherapy infliximab adalimumab etanercept ustekinumab pharmacoepidemiology exposure melanoma

    Coverage

    Universe

    {
    "level_sex_clusion_I": [
    {
    "value": "Male",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008297"
    }
    },
    {
    "value": "Female",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
    }
    }
    ],
    "level_age_clusion_I": [
    {
    "value": "Young Adult (19 to 24 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D055815"
    }
    },
    {
    "value": "Adult (25 to 44 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000328"
    }
    },
    {
    "value": "Middle Aged (45 to 64 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008875"
    }
    },
    {
    "value": "Aged (65 to 79 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000368"
    }
    },
    {
    "value": "Aged, 80 and over (80 years and more)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000369"
    }
    }
    ],
    "level_type_clusion_I": [
    "Patients population"
    ],
    "level_type_clusion_other": "",
    "clusion_I": "Inclusion criteria: - Patients aged 18 or over; - Attending or hospitalised in services participating in the study; - Has been informed of the research objectives and outcome and has signed an informed consent form to participate; - Cutaneous psoriasis (clinical diagnosis); - Justifying the prescription of major systemic therapy (Methotrexate or Cyclosporine or biotherapy) and belongs to one of the following 3 groups: - Patients beginning biotherapy (Infliximab, Adalimumab, Etanercept, Ustekinumab and other biotherapy entering the market) AND who have not been previously exposed; - Patients beginning biotherapy AND who have been already exposed. ",
    "clusion_E": "biotherapy) for at least 3 months (Methotrexate or Cyclosporine) AND for which no biotherapy treatment is planned within the next 6 months AND are naive to all biotherapy.criteria: - Patients for whom cutaneous psoriasis is not the main reason for systemic treatment (biotherapy or conventional treatment); treatment justified by psoriatic arthritis, concomitant Crohn's disease, etc. - Patients unable to comply with the cohort monitoring (unreachable by phone, unable to complete the self -administered questionnaire) or whose follow-up is expected to be difficult."
    }

    Producers and sponsors

    Primary investigators
    Name
    Olivier;CHOSIDOW
    Florence;TUBACH
    Producers
    Name Role
    SOCIETE FRANÇAISE DE DERMATOLOGIE ET DE PATHOLOGIE SEXUELLEMENT TRANSMISSIBLE sponsor
    ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP) sponsor
    MSD FRANCE sponsor
    PFIZER (FRANCE) sponsor
    JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE) sponsor
    ABBVIE sponsor
    Funding Agency/Sponsor
    Name
    ABBOTT FRANCE
    AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)
    ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)
    JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE)
    MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES
    MSD FRANCE
    PFIZER (FRANCE)
    Other Identifications/Acknowledgments
    Name
    The PSOBIOTEQ meets the objective of the European PSONET project to develop standardised procedures for the sharing and analysis of national data registers for the long-term monitoring of the efficacy and safety of systemic psoriasis treatment.

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']

    Sampling Procedure

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Questionnaires

    Access on specific project only

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2012-01-01 2020-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"Transcription","vocab":"CESSDA"},"value":"Converting or copying information into a structured record"}

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception

    Quality standards

    Quality standards
    Standard
    ['MeDRA']

    Data Access

    Access conditions

    Data belongs to AP-HP and cannot be used or sent to a third party without prior consent. Access to data is by request to the Psobioteq project scientific committee; Access shall also be subject to a partnership contract signed between AP-HP and the legal representative of the requesting team specifying the terms and conditions of data provision. Every laboratory participating in the Psobioteq study will have access to data involving their product.

    Availability Status

    {"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}

    Notes

    Psonet study variables (European study) will be sent to the European registry according to the terms outlined in a specific document.

    Contacts

    Contacts
    Name Email
    Olivier;CHOSIDOW olivier.chosidow@aphp.fr
    Florence;TUBACH florence.tubach@aphp.fr

    Metadata production

    DDI Document ID

    FRESH-PEF8863-en

    Producers
    Name Affiliation
    SARRA POCHON ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)
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