PREDICT - A real world study of brodalumab in patients with psoriasis
Research type
Research Study
Full title
A prospective, real world, observational study to evaluate outcomes of brodalumab (Kyntheum®) treatment in patients with moderate-to-severe plaque psoriasis in the United Kingdom and Ireland
IRAS ID
272912
Contact name
Girish Gupta
Contact email
Sponsor organisation
LEO Pharma UK/IE
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 0 months, 7 days
Research summary
This is a prospective, single cohort, real world, observational study of the outcomes of brodalumab treatment used in normal clinical practice for treatment of moderate to severe plaque psoriasis. This study will be conducted in 15 to 25 NHS (UK) and/ Health Service Executive (HSE; Ireland) hospitals.
The population for this study is adult patients diagnosed with moderate-to-severe plaque psoriasis who receive treatment with brodalumab as part of their standard clinical care. It is expected to recruit 200 patients in total.
The study is based on prospective collection of data from patients’ medical records and from Patient Reported Outcome (PRO) questionnaires that will be collected through the ClinPal™ phone app or via a paper questionnaire where the patient does not have a smartphone.
Patients' participation will be 56 weeks, during which they will complete two PRO questionnaires on eight occasions. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required except completing the questionnaires, which will NOT be used to inform clinical care of individual patients during the study.
REC name
London - Surrey Research Ethics Committee
REC reference
20/LO/0439
Date of REC Opinion
17 Apr 2020
REC opinion
Further Information Favourable Opinion