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
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