Status: Ongoing First registered on: 25/02/2019
Last updated on: 07/07/2020
1. Study identification
EU PAS Register NumberEUPAS28457
Official titleAn Observational Post-Authorisation Safety Study of Skilarence in European Psoriasis Registers
Study title acronym
Study typeObservational study
Brief description of the studyPsoriasis is a chronic inflammatory skin disorder that results from complex interactions between genes, the immune system, and environmental factors, although the exact cause remains unclear. Skilarence (dimethyl fumarate; DMF) received European marketing authorisation for the treatment of moderate to severe chronic plaque psoriasis in adult patients on 23 June 2017. This study aims to evaluate the long-term safety of Skilarence used for the treatment of patients with moderate to severe psoriasis. The study will evaluate whether the use of Skilarence is associated with an increased risk of serious infections (including serious opportunistic infections such as progressive multifocal leukoencephalopathy), malignancies, or renal impairment as compared with conventional (non-biologic) systemic therapies. In addition, the study aims to describe the use of Skilarence in patient subgroups for which there is missing information. The study is a long-term, non-interventional, observational post-authorisation safety study that will use a prospective cohort design, and data from established registers of patients with psoriasis treated with systemic therapies in Germany, Spain, and the UK and Republic of Ireland.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Rivero
First name Elena
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3
Fundación de la Academia Española de Dermatología y Venereología, Madrid, Spain
University Medical Center Hambug-Eppendorf (UKE), Hamburg, Germany
British Association of Dermatologists Biologics Register Limited (BADBIR), Manchester, United Kingdom
Countries in which this study is being conducted
International study

Germany
Ireland
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/09/201817/12/2018
Start date of data collection29/03/201914/05/2019
Start date of data analysis01/04/2027
Date of interim report, if expected
Date of final study report31/03/2028
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAlmirall S.A.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Rivero
First name Elena
Address line 1Av. Diagonal, 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34933622802 
Alternative phone number 
Fax number (incl. country code) 
Email address erivero@rti.org
Public Enquiries
Title Dr 
Last name Rivero 
First name Elena 
Address line 1Av. Diagonal, 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain 
Phone number (incl. country code)34933622802 
Alternative phone number 
Fax number (incl. country code) 
Email address erivero@rti.org 
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