Status: Ongoing First registered on: 19/06/2018
Last updated on: 22/07/2020
1. Study identification
EU PAS Register NumberEUPAS24484
Official titleLong term, prospective, observational cohort study evaluating the safety profile in patients with highly active relapsing multiple sclerosis (RMS) newly started on oral cladribine
Study title acronymCLARION
Study typeObservational study
Brief description of the studyThis 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during 10 years, as each patient will be followed-up for a period of 10 years, except if s/he is lost to follow-up, or withdrawn his/her consent, or die before the end of the follow-up period.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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEPID Research
Department/Research group
Organisation/affiliationEPID Research Oy
Website/Homepagewww.epidresearch.com
Details of (Primary) lead investigator
Title Dr
Last name Korhonen
First name Pasi
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Australia
Belgium
Denmark
Finland
France
Germany
Italy
Netherlands
Norway
Spain
Sweden
Switzerland
Turkey
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/10/201705/10/2017
Start date of data collection14/09/201825/09/2018
Start date of data analysis01/09/2033
Date of interim report, if expected30/09/2021
Date of final study report06/12/2034
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMerck KGaA100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358-50-3652990 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Korhonen 
First name Pasi 
Address line 1EPID Research Oy 
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358-50-3652990 
Alternative phone number 
Fax number (incl. country code) 
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