PsABIOnd

  • Research type

    Research Study

  • Full title

    Assessment of Guselkumab (Tremfya®) and IL-17 Inhibitor Therapies in Patients with Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study

  • IRAS ID

    302608

  • Contact name

    Stefan Siebert

  • Contact email

    Stefan.Siebert@glasgow.ac.uk

  • Sponsor organisation

    Janssen EMEA

  • Duration of Study in the UK

    5 years, 3 months, 21 days

  • Research summary

    This is a prospective, observational, cohort study to collect data on adult patients who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting guselkumab (GUS) or an IL-17 inhibitor therapy as a first, second, third, or fourth line of PsA therapy as per standard clinical practice.
    This will allow for a comparison between guselkumab and IL-17i treatments modalities, which includes their persistence, presence, effectiveness, treatment patterns, responses and safety, from the standard of care data and from the patients perspective through the electronic patient reported outcomes that will be collected.

    This study is being sponsored by Janssen EMEA and will be conducted across several countries in approximately 100 sites. It is planned that 1000 patients will be enrolled - 500 GUS / 500 IL-17i; individual participation will last approximately 3 years (+/- 3 months)

  • REC name

    London - Surrey Research Ethics Committee

  • REC reference

    21/LO/0642

  • Date of REC Opinion

    12 Nov 2021

  • REC opinion

    Further Information Favourable Opinion