Study identification

EU PAS number

EUPAS25027

Study ID

49924

Official title and acronym

Pregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database study (CLEAR)

DARWIN EU® study

No

Study countries

Denmark
Finland
France
Germany
Norway
Sweden
United Kingdom

Study description

The design of this pregnancy PASS is a cohort study based on secondary use of data from various automated healthcare databases (AHDB) and registers in 6 European countries: Denmark, Finland, France, Germany, Norway, Sweden, and Scotland (United Kingdom).
Women with Multiple Sclerosis (MS) who were exposed to oral cladribine during pregnancy and/or within 6 months before their last menstrual period (LMP) (i.e. exposure period, which correspond to the at-risk period for pregnancy outcomes, major congenital anomalies (MCA) in infants), or pregnancies fathered by men with MS treated with oral cladribine within 6 months before the LMP, will be identified in the selected databases/registers. Data will be retrieved on pregnancies and their outcomes, and infants for MCA, and hearing loss.
Comparison of pregnancy outcomes will be conducted in pregnant women with MS between the exposed cohort (exposure to oral cladribine within the at-risk period) and the unexposed cohort (unexposed to any Disease-modifying drug [DMD] during the at-risk period, which can vary from 3 to 24 months according to the DMD) and in pregnant women whose pregnancy is fathered by men with MS between the exposed cohort (pregnancy fathered by men with MS exposed to oral cladribine within the at-risk period) and the unexposed cohort (pregnancy fathered by men with MS unexposed to any DMD during the at-risk period, which can vary from 3 to 6 months before the LMP according to the DMD .
In the selected data sources, pregnancies will be followed until the outcome of the pregnancy is known, and live births resulting from an identified pregnancy will be followed for up to one year of age.

Study status

Ongoing
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
MEMO Research, University of Dundee
United Kingdom (Northern Ireland)
First published:
17/05/2024
Institution Educational Institution Not-for-profit ENCePP partner
Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway;
Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;
Hospices Civils de Lyon, Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation—Hôpital Neurologique Pierre Wertheimer, Bron Cedex, France;
Department of Neurology, St. Joseph and St. Elisabeth Hospital, Ruhr University, Bochum, Germany

Contact details

Alejandro Arana

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

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Actual:

Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Merck Healthcare KGaA
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)