Psoriasis Study of Health Outcomes (PSoHO) - I1F-MC-B007

  • Research type

    Research Study

  • Full title

    Psoriasis Study of Health Outcomes (PSoHO) – an International Observational Study of 3-Year Health Outcomes in the Biologic Treatment of Moderate-to-Severe Plaque Psoriasis

  • IRAS ID

    251961

  • Contact name

    Derrick Phillips

  • Contact email

    derrick70@doctors.org.uk

  • Sponsor organisation

    Lilly Deutschland GmbH

  • Clinicaltrials.gov Identifier

    EUPAS24207, EU PAS Register

  • Duration of Study in the UK

    4 years, 6 months, 1 days

  • Research summary

    This study is a 36-month prospective, multi-center, international, non-interventional cohort study reflecting treatment within real-world settings of patients with moderate-to-severe plaque psoriasis who initiate their first biologic or are switched to a new biologic therapy (including biosimilars). The study will have a 24-month enrollment and a 36-month follow-up period.
    Data collection will occur at baseline, first postbaseline visit (suggested window of observation: 12±4 weeks following initiation of or switch to a new biologic), 6 months postbaseline and then at 6 months visits until study completion. Subjects who discontinue biological treatment will remain in the study.
    Countries participating in this study may include (but is not restricted to) France, Spain, Italy,Germany, the United Kingdom, Sweden, Netherlands, Romania, Australia, Korea, Colombia, Argentina, Mexico, Saudi Arabia, Denmark, Poland, Hungary, Canada, Brazil, Taiwan, Portugal,Israel, and United Arab Emirates.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    18/NW/0736

  • Date of REC Opinion

    25 Oct 2018

  • REC opinion

    Favourable Opinion