Study identification

EU PAS number

EUPAS24484

Study ID

47525

Official title and acronym

Long term, prospective, observational cohort study evaluating the safety profile in patients with highly active relapsing multiple sclerosis (RMS) newly started on oral cladribine − CLARION

DARWIN EU® study

No

Study countries

Australia
Belgium
Canada
Croatia
Czechia
Denmark
Finland
France
Germany
Italy
Kuwait
Lebanon
Netherlands
Norway
Sweden
Switzerland
Türkiye
United States

Study description

This Post-authorisation safety study (PASS) is a multi-country, multi-center, long-term, prospective, observational study evaluating the safety in patients with highly active relapsing remitting multiple sclerosis (R(R)MS) newly initiating oral cladribine (cladribine cohort) as compared to R(R)MS patients newly initiating fingolimod (comparator cohort).
The study is projected to last for a maximum of 15 years, with a maximum 5-year recruitment period until both cohorts have reached 4,000 patients and with a follow-up of 10 years for each patient.
The study will only use pre-existing registries or databases and is based on a mixed data collection model relying on secondary use of data and additional (primary) data collection. For each patient, data collection will begin after the signature of the informed consent form – noting that patient consent applies to countries with primary data collection will be conducted and to some countries where secondary use of data will be performed –and continue during 10 years, as each patient will be followed-up for a period of 10 years, except if s/he is lost to follow-up, or withdrawn his/her consent, or die before the end of the follow-up period.
Follow-up will continue regardless of oral cladribine or fingolimod discontinuation.

Study status

Ongoing
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Irene Bezemer

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Merck 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)