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Assessing the Long Term Effectiveness and Safety of Biotherapies in the Treatment of Cutaneous Psoriasis

NCT01617018 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4613

Last updated 2021-09-10

No results posted yet for this study

Summary

PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis. It is resulting from the merging of two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing on safety issues, and Pso-TEQ, developed by industrials at the request of the French Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues.

The overall general objective of PSOBIO is to assess "in real life" the safety and efficacy of biotherapies in the treatment of cutaneous psoriasis in comparison with major conventional systemic therapy while Pso-TEQ has a descriptive objective concerning the modalities of use of biological therapies "in real life" and long-term benefit.

Conditions

Sponsors & Collaborators

  • French Health Products Safety Agency

    collaborator OTHER_GOV

  • Société de Dermatologie Française

    collaborator OTHER

  • Janssen, LP

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • AbbVie

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Olivier Chosidow, Md, Phd · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2021-09-05
Completion
2021-09-05

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01617018 on ClinicalTrials.gov