CLEVER: CLadribine tablets - EValuation of therapy satisfactio

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00013587
• Lead Sponsor: Merck Serono GmbH, Germany

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-16
• Study Completion: 2020-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

· Patients (male or female) aged 18 years and over
· All patients eligible to receive Cladribine tablets as per registered label
· Patients using Cladribine tablets for the first time.
- Inclusion to the NIS can occur at treatment initiation or within 24 weeks after treatment initiation
· Signed informed consent

Exclusion Criteria

· Existing pregnancy or lactation
· Contraindications to use of Cladribine tablets
according to the Summary of Product Characteristics

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is overall treatment satisfaction with Cladribine tablets as assessed by the Global Satisfaction subscale score of the questionnaire TSQM-14 (Version 1.4) in week 24.

Secondary Outcome Measures

Name	Time	Method
Secondary Objective are: <br>To assess treatment satisfaction with Cladribine<br>tablets with special focus on patient perceived<br>effectiveness, tolerability, convenience; <br> <br>To describe patients’ characteristics and profile prior to Cladribine treatment (demographics, prior MS treatments, disease severity); <br><br>To evaluate predictors of treatment satisfaction; and Participation in Patient Support Program (PSP).