G35
Conditions
Interventions
Group 1: Patients who suffer of multiple sclerosis and are already being treated with Cladribin will be asked whether they would like to participate in this observational trial. If they confirm their
Sponsors
Merck Serono GmbH, Germany
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: · Existing pregnancy or lactation · Contraindications to use of Cladribine tablets according to the Summary of Product Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary Objective are: To assess treatment satisfaction with Cladribine tablets with special focus on patient perceived effectiveness, tolerability, convenience; To describe patients’ characteristics and profile prior to Cladribine treatment (demographics, prior MS treatments, disease severity); To evaluate predictors of treatment satisfaction; and Participation in Patient Support Program (PSP). | — |
Countries
Germany
Contacts
Public ContactAnita Posevitz-Fejfár
Merck Serono GmbH
Outcome results
None listed