Study identification

PURI

https://redirect.ema.europa.eu/resource/46397

EU PAS number

EUPAS21769

Study ID

46397

Official title and acronym

Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids: Protopic JOint European Longitudinal Lymphoma and skin cancer Evaluation (JOELLE) Study

DARWIN EU® study

No

Study countries

Denmark
Netherlands
Sweden
United Kingdom

Study description

The 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.

Study status

Finalised
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
Southern Denmark University Denmark

Contact details

Alejandro Arana

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

LEO Pharma A/S
Study protocol
Initial protocol

Protopic JOELLE Protocol Final 30Jun2017_Redacted

English (5.81 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)