Status: Finalised First registered on: 24/07/2013
Last updated on: 15/05/2018
1. Study identification
EU PAS Register NumberEUPAS4357
Official titleRisk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids
Study title acronymJOELLE
Study typeObservational study
Brief description of the studyProtopic JOint European Longitudinal Lymphoma and skin cancer Evaluation (JOELLE) Study is a European, multinational cohort study to assess the risk of skin cancer and lymphoma in the pediatric and adult population treated with topical tacrolimus, pimecrolimus, and corticosteroids and in the not-treated population. The study design is a cohort study in populations from four automated health databases: the PHARMO Record Linkage System in the Netherlands; Clinical Practice Research Datalink (CPRD), in the UK; the Danish National Health Database (through research center Southern Denmark University) in Denmark; and the Swedish National Health Databases (through research center Karolinska Institutet) in Sweden. The study will be coordinated by RTI Health Solutions in Spain and the United States. The study endpoints are nonmelanoma skin cancer, malignant melanoma, Hodgkin lymphoma, non-Hodgkin lymphoma, and cutaneous T cell lymphoma. Exposure propensity scores will be used to frequency match users of tacrolimus and users of pimecrolimus with users topical corticosteroids. The not-treated cohort will be individually matched to the corticosteroids cohort identified for comparison with users of tacrolimus. The study cohorts will be followed from the start date for the first occurrence of any one of the study endpoints. A minimum lag time of 6 months will be assumed between the start of exposure and the occurrence of the study endpoints. Person-years of follow-up will be classified according to ever use, single use, and switching/multiple use of tacrolimus and pimecrolimus and to cumulative dose and duration of exposure. The main exposure of interest will be the cumulative dose of topical tacrolimus and pimecrolimus. Stratified analysis and Mantel-Haenszel methods will be used to estimate crude and adjusted incidence rate ratios for each study endpoint and exposure category comparing users of tacrolimus and users of pimecrolimus with users of corticosteroids.
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/Homepagewww.rtihs.org
Details of (Primary) lead investigator
Title Dr
Last name Castellsague
First name Jordi
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?5

Countries in which this study is being conducted
International study

Denmark
Netherlands
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/201304/01/2013
Start date of data collection31/12/201201/03/2013
Start date of data analysis01/04/201302/09/2013
Date of interim report, if expected
Date of final study report31/12/201530/11/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstellas Pharma Europe B.V .100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Castellsague
First name Jordi
Address line 1Trav. Gracia, 56, Atico 1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain
Phone number (incl. country code)34932417763 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address castellsague@rti.org
Public Enquiries
Title Dr 
Last name Castellsague 
First name Jordi 
Address line 1Trav. Gracia, 56, Atico 1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain 
Phone number (incl. country code)34932417763 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address castellsague@rti.org 
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