Study identification

EU PAS number

EUPAS7346

Study ID

28499

Official title and acronym

A prospective, multicenter, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRADA® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis (RMS) (GZ402673-OBS13434)

DARWIN EU® study

No

Study countries

Australia
Austria
Belgium
Bulgaria
Canada
Croatia
Denmark
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Mexico
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom

Study description

A prospective, multicenter, observational PASS to evaluate the long term safety profile of LEMTRADA® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis (RMS). The specific Adverse Events of Special Interests (AESIs) to be monitored include but are not limited to serious infection serious infection, malignancy, and auto-immune mediated conditions including ITP, cytopenias, thyroid disorders, and nephropathies including anti-GBM disease for a period of 10 years. The overall goal of the study is to further evaluate the necessary duration and appropriate conditions of monitoring LEMTRADA treatment in RMS patients by determining the incidence of AESIs to further characterize the long-term safety profile.

Study status

Ongoing
Research institutions and networks

Institutions

Sanofi
First published:
01/02/2024
Institution

Contact details

Trial Transparency Team Trial Transparency Team

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sanofi
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)