eDAILY by PsABIOnd - an eHealth substudy
Research type
Research Study
Full title
A Substudy of CNTO1959PSA4001 (PsABIOnd) to Assess the Qualitative Impact of Guselkumab (TREMFYA®) and IL-17 Inhibitor Therapies in Patients with Psoriatic Arthritis via a Digital and Wearable Patient Application
IRAS ID
316463
Contact name
Stefan Siebert
Contact email
Sponsor organisation
Janssen EMEA
Duration of Study in the UK
2 years, 7 months, 0 days
Research summary
This is a substudy of protocol CNTO1959PSA4001 (PsABIOnd) which 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. The purpose of the main study is to compare guselkumab and IL-17i treatments modalities, which includes their persistence, effectiveness, treatment patterns, responses and safety, from the standard of care data and from the patient’s perspective through the electronic patient reported outcomes that will be collected. Data collection for patients who consent to participate in the substudy will follow the same framework as outlined in the main study protocol. Additionally, patients in the substudy will complete Smartphone-Based Patient App assessments and will have actigraphy (smart watch) data collected continuously, as detailed in the substudy protocol.
This study is being sponsored by Janssen EMEA and will be conducted across several countries. It is planned that 150 patients will be enrolled and individual participation will last 26-30 weeks.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
22/YH/0207
Date of REC Opinion
13 Sep 2022
REC opinion
Further Information Favourable Opinion