POSITIVE Psoriasis Study assessing use of tildrakizumab in RWE setting
Research type
Research Study
Full title
A multicenter, prospective observational RWE study to assess Patient-reported wellbeing using tildrakizumab in a live setting – POSITIVE Study
IRAS ID
298258
Contact name
Philip Laws
Contact email
Sponsor organisation
Almirall S.A.
Duration of Study in the UK
3 years, 4 months, 30 days
Research summary
This is an observational (non-interventional) study to evaluate treatment and outcomes in patients with moderate to severe psoriasis treated with Tildrakizumab in the post-marketing setting according to routine clinical practice. The decision to initiate treatment of Tildrakizumab will be made by the patient's doctor according to their normal practice and is not mandated by the study protocol. The decision to initiate treatment of Tildrakizumab will be made independently of the decision to include the patient in the study. Only patients already evaluated by doctors to be eligible for treatment with Tildrakizumab can be included in the study.
This study aims to assess overall health-related wellbeing (evaluated through various questionnaires) in patients treated with tildrakizumab according to the marketing authorization and routine clinical practice in the long-term (24 months follow up period). In addition, this study will assess the long term benefit of tildrakizumab treatment on the control of skin manifestations, physician and patient treatment satisfaction and safety and tolerability of tildrakizumab in real world clinical practice.
Tildrakizumab treatment will be managed and followed-up by the patient’s doctor as per their normal practice.
This study is being sponsored by Almirall S.A. and will be conducted in the UK at around 10-15 sites. Sites will be public hospitals or outpatient offices where patients with moderate-to-severe plaque psoriasis are usually managed. The participating physicians will be dermatologists. It is planned that 40-60 patients will be enrolled in the UK. Individual participation will last approximately 24 months.
REC name
London - Hampstead Research Ethics Committee
REC reference
21/PR/0883
Date of REC Opinion
21 Sep 2021
REC opinion
Further Information Favourable Opinion