Study identification

EU PAS number

EUPAS21870

Study ID

46551

Official title and acronym

Malignancies in Multiple Sclerosis: multi-country cohort database studies (feasibility study) (MALBEC-f)

DARWIN EU® study

No

Study countries

Denmark
France
Netherlands
United States

Study description

The pattern of malignancies in the cladribine clinical program in multiple sclerosis (MS) (all exposed subjects) did not show an obvious difference compared to the available data on malignancies in the general population, or in MS patients. There is no obvious evidence of an increase of the risk of a particular tumor type in cladribine treated subjects compared to European reference populations. No dose-relationship could be found. The effect of age, immunomodulators (IM) and immunosuppressants (IS) treatments on the risk of malignancy in patients with MS is currently uncertain. MS patients seem to have a similar risk of malignancy than the general population but further studies using external data sources are needed to estimate the risk in MS as compared to general population. In this context, this study will provide estimates of malignancies incidence for a cohort of MS patients compared to non-MS patients of the general population, and for a cohort of MS patients newly treated with MS modifying drugs (DMDs), according to the type of medication used. This study will be done in 4 countries: France, the Netherlands, Denmark, United States. The overall results will be used with a view to a later post-marketing evaluation of cladribine.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Patrick Blin

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

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

More details on funding

Merck KGaA
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable