Prospective Observational Study Aimed at Evaluating Treatment Satisfaction and Effectiveness in Patients with Relapsing Multiple Sclerosis Starting CLADRibinE TAbLets (CLADREAL)

Study identification

• EU PAS number:
  EUPAS49334
• Study ID:
  49335
• Official title and acronym:
  Prospective Observational Study Aimed at Evaluating Treatment Satisfaction and Effectiveness in Patients with Relapsing Multiple Sclerosis Starting CLADRibinE TAbLets (CLADREAL)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This is an observational, multicenter, prospective study which aims to assess the effectiveness of cladribine tablets, in terms of treatment satisfaction and other patient reported and clinical outcomes in patients with relapsing multiple sclerosis (RMS) initiating treatment with cladribine tablets in a real world setting.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck Healthcare KGaA

Germany

Study timelines

Date when funding contract was signed

Actual: 27/04/2022

Study start date

Planned: 05/12/2022

Actual: 22/12/2022

Data analysis start date

Planned: 04/03/2027

Date of interim report, if expected

Planned: 31/05/2024

Date of final study report

Planned: 31/08/2027

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