An observational, multicenter, prospective, phase IV study evaluating cladribine tablets’ effects on PROs and their correlation with clinical and biometric parameters using Health Technology in subjects with highly-active RMS at their first switch (CLADFIT-MS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43894
• EU PAS number:
  EUPAS43893
• Study ID:
  43894
• Official title and acronym:
  An observational, multicenter, prospective, phase IV study evaluating cladribine tablets’ effects on PROs and their correlation with clinical and biometric parameters using Health Technology in subjects with highly-active RMS at their first switch (CLADFIT-MS)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck Healthcare KGaA

Germany

Study timelines

Date when funding contract was signed

Planned: 27/07/2020

Study start date

Planned: 30/04/2021

Actual: 12/05/2021

Data analysis start date

Planned: 31/01/2025

Actual: 11/03/2025

Date of final study report

Planned: 31/07/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck KGaA

Regulatory

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