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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47525
• 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during 10 years, as each patient will be followed-up for a period of 10 years, except if s/he is lost to follow-up, or withdrawn his/her consent, or die before the end of the follow-up period.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

Study timelines

Date when funding contract was signed

Planned: 05/10/2017

Actual: 05/10/2017

Study start date

Planned: 14/09/2018

Actual: 25/09/2018

Data analysis start date

Planned: 01/09/2033

Date of interim report, if expected

Planned: 30/09/2021

Actual: 30/09/2021

Date of final study report

Planned: 06/12/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck KGaA

Study protocol

Initial protocol

20180626_MS700568-0002 CLARION protocol v1.0__Redacted

Updated protocol

MS700568_0002-Protocol-CLARION-v4.0_Redacted

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)