Long-term effectiveness of cladribine in patients previously treated with oral cladribine: a Real-World Evidence analysis using data from the Italian Registry of Multiple Sclerosis (CLARINET-MS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25784
• EU PAS number:
  EUPAS25783
• Study ID:
  25784
• Official title and acronym:
  Long-term effectiveness of cladribine in patients previously treated with oral cladribine: a Real-World Evidence analysis using data from the Italian Registry of Multiple Sclerosis (CLARINET-MS)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study status:
  Planned

Research institutions and networks

Institutions

Merck Healthcare KGaA

Germany

Study timelines

Date when funding contract was signed

Actual: 01/08/2018

Study start date

Planned: 15/10/2018

Date of final study report

Planned: 21/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck KGaA

Study protocol

Initial protocol

20181004_MS700568_0027_EnCepP_CTP_Redacted version for review_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable