Status: Finalised First registered on: 16/01/2018
Last updated on: 22/11/2019
1. Study identification
EU PAS Register NumberEUPAS21769
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 studyThe Protopic 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 untreated population. The primary objective of the study is to estimate the incidence rate ratios of skin cancer and lymphoma in the pediatric and adult populations for new users of topical tacrolimus and topical pimecrolimus compared with users of moderate- to high-potency topical corticosteroids. Secondary objectives of the study are (1) to estimate the incidence rate ratios of skin cancer and lymphoma in users of moderate- to high-potency topical corticosteroids compared with persons not treated with topical tacrolimus, pimecrolimus, or corticosteroids and (2) to describe the patterns of use and the characteristics of users of topical tacrolimus, pimecrolimus, and corticosteroids. Phase I of the study (EUPAS4357), involving the period 2002-2011, has been completed and the report was submitted to the EMA in December 2015. In the JOELLE Extension, the study has been extended for 4 additional years (2012-2015) in order to increase the number of exposed patients and the length of follow-up. Data beyond 2015 may be available in some databases and will be included in the analysis.
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
Details of (Primary) lead investigator
Title Dr
Last name Arana
First name Alejandro
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

Southern Denmark University, Denmark
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 signed01/10/201728/09/2017
Start date of data collection15/11/201727/10/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/201920/09/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesLEO Pharma A/S100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Arana
First name Alejandro
Address line 1Av. Diagonal, 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34933622805 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address aarana@rti.org
Public Enquiries
Title Dr 
Last name Arana 
First name Alejandro 
Address line 1Av. Diagonal, 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain 
Phone number (incl. country code)34933622805 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address aarana@rti.org 
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