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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)
Florence Tubach, Olivier Chosidow
Metadata
DDI/XML JSON
Created on
Nov 15, 2025
Last modified
Nov 15, 2025
Page views
3
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • 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
    France
    Abstract

    PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or conventional treatment) for moderate to severe cutaneous psoriasis. PSOBIOTEQ is the result of merging two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists focusing on safety issues, and Pso-TEQ, developed by industrial teams at the request of the French Transparency Commission (Haute Autorité de Santé) that focuses on usage issues. The exposure of interest is the biological therapy exposure: Infliximab, Adalimumab, Etanercept and Ustekinumab. The general objective of PSOBIO is to assess the safety and efficacy of biotherapy in the treatment of cutaneous psoriasis "in real life" compared with conventional systemic therapy. However, Pso-TEQ has a descriptive objective concerning the usage methods of biological therapies "in real life" and the long-term benefits.

    Kind of Data

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

    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary URI
    Oncology health theme
    Dermatology health theme
    cim-11 http://id.who.int/icd/entity/322865591
    cim-11 http://id.who.int/icd/entity/322865591
    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": [
    "Male",
    "Female"
    ],
    "level_age_clusion_I": [
    "Young Adult (19 to 24 years)",
    "Adult (25 to 44 years)",
    "Middle Aged (45 to 64 years)",
    "Aged (65 to 79 years)",
    "Aged, 80 and over (80 years and more)"
    ],
    "level_type_clusion_I": [
    "Patients population"
    ],
    "level_type_clusion_other": "",
    "clusion_I": "",
    "clusion_E": ""
    }

    Producers and sponsors

    Primary investigators
    Name
    Florence Tubach
    Olivier Chosidow
    Producers
    Name Role
    ABBVIE sponsor
    JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE) sponsor
    MSD FRANCE sponsor
    PFIZER (FRANCE) sponsor
    ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP) sponsor
    Funding Agency/Sponsor
    Name
    ABBOTT FRANCE
    JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE)
    MSD FRANCE
    PFIZER (FRANCE)
    AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)
    ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)
    MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES

    Study authorization

    Agency
    Agency name
    CNIL

    Sampling

    Sample frame

    Unit Type

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

    Sampling Procedure

    ['Other']

    Survey instrument

    Questionnaires

    Access on specific project only

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2012 2020
    Time Method

    Longitudinal or cohort study

    Mode of data collection
    • 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

    Restricted access

    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
    Florence Tubach florence.tubach@aphp.fr
    Olivier Chosidow olivier.chosidow@aphp.fr

    Metadata production

    DDI Document ID

    FRESH-PEF8863-en

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