Psoriasis prospective observational study
Research type
Research Study
Full title
Multi-country prospective observational, cohort study of patients with moderate to severe chronic plaque psoriasis (VALUE).
IRAS ID
269001
Contact name
SIMINA STEFANESCU
Contact email
Sponsor organisation
AbbVie Ltd
Duration of Study in the UK
4 years, 6 months, 0 days
Research summary
Psoriasis is a chronic disease which is characterised by inflammation of the skin, resulting in scaly, red, and raised plaques. It is associated with high burden of illness including a negative impact on quality of life. Between 1.5% and 5% of people in developed countries are affected by psoriasis. There is increasing evidence that psoriasis is correlated with obesity, diabetes, depression and cardiovascular health.
Most patients are treated topically, with cream, however, according to health guidelines, patients with moderate to severe psoriasis should be treated with oral or biologic therapies.
Treatment is based on controlling symptoms, but often lacks continued effect over a long period of time. There are a number of new biologic treatments being used to treat psoriasis, including risankizumab, which has repeatedly had positive results in clinical trials. However, real-world evidence lacking on the continued effect of risankizumab compared to other biologic treatments. The aim of this study to better understand its sustained response over time and impact on patient outcomes in real world clinical settings.
This is an observational study of patients with moderate to severe plaque psoriasis in the United Kingdom, and approximately 20 other countries worldwide. The study population will consist of adult subjects (aged ≥18 years) with moderate to severe plaque psoriasis. A total study target sample of 180 patients will be recruited from the UK over approximately 15 to 20 NHS hospitals.
The study research data will be obtained from the medical records and entered into an electronic case report form (eCRF) by the physician or member of the research team. One eCRF will be completed for each patient per visit (every 3-4 months as per clinical practice) for up to 3 years.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1401
Date of REC Opinion
9 Sep 2019
REC opinion
Further Information Favourable Opinion