Skilarence Retrospective Post Authorisation Safety Study (RETROSKIL)
Research type
Research Study
Full title
Retrospective chart review to assess the effectiveness of the Skilarence® risk minimisation activities in daily practice – a post-authorisation safety study (PASS)
IRAS ID
273266
Contact name
Richard Warren
Contact email
Sponsor organisation
Almirall
Clinicaltrials.gov Identifier
EUPAS29842, Study listed on EU PAS register
Duration of Study in the UK
0 years, 5 months, 27 days
Research summary
The purpose of this multi-country post authorisation safety study is to ascertain whether the product safety guidelines for Skilarence, together with the educational material distributed to treating physicians by the Sponsor, have been understood and adhered to, when treating patients with moderate to severe plaque psoriasis in routine clinical practice.
The aim of this multi country study is to collect retrospective information from patient records to ensure that correct blood monitoring is undertaken prior to each dose of Skilarence is administered.
Patients 18 years or above who have moderate to severe plaque psoriasis and who have been treated with Skilarence at least one year prior to the study start date can be included, as long as they have not participated in any other trial during the treatment period.
The information which will be collected from the patients medical records at start of treatment with Skilarence will include demographics, characteristics of their psoriasis, prior medical history, any other medications and diseases present. The starting dosage of Skilarence and changes in the dosage during the treatment period, as well as any incidences of serious infection, adverse drug reaction both serious and non serious will also be recorded.
As this study is retrospective in nature there is no patient intervention involved. Patient data will be pseudonymised and not identifiable. It is estimated that data collection for the study will end 6 months after study start up.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
21/WM/0008
Date of REC Opinion
8 Jan 2021
REC opinion
Further Information Favourable Opinion