Data collection survey study ELEVATE protocol 1.1 dated 28 March 2022
Research type
Research Study
Full title
Observational study of treatment history, quality of life, treatment satisfaction, and disease symptom severity in adult patients with moderate to severe plaque psoriasis treated with bimekizumab in routine clinical practice
IRAS ID
315744
Contact name
Philip Hampton
Contact email
Sponsor organisation
UCB Bioscience GmbH
Clinicaltrials.gov Identifier
262985, Parexel ref
Duration of Study in the UK
3 years, 0 months, 25 days
Research summary
In order to improve medical care continuously, it is very important to get scientific information about the safety and efficacy of drugs. This includes the drugs for the treatment of moderate to severe plaque psoriasis.
The participant has been prescribed Bimzelx® (bimekizumab) by their treating physician according to standard medical practice and is being asked to allow collection of their data. This data collection survey is a non-interventional study (NIS) which is initiated, managed, and financed by UCB Biopharma SRL who is the Sponsor of this NIS.
The purpose of this NIS is to collect medical information about the treatment after having taken Bimzelx® so that a record of whether Bimzelx® causes any side-effects, and see whether Bimzelx® does or does not have any effect on the participant’s health-related quality of life. In addition, information on the degree of treatment satisfaction with Bimzelx® will be collected.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0138
Date of REC Opinion
7 Jul 2022
REC opinion
Further Information Favourable Opinion