A study to evaluate specific unmet needs in the current clinical practice of multiple sclerosis
Not Applicable
- Conditions
- Relapsing multiple sclerosisNervous System DiseasesMultiple sclerosis
- Registration Number
- ISRCTN40939838
- Lead Sponsor
- Roche Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1250
Inclusion Criteria
1. RRMS or rSPMS, diagnosed by revised McDonald 2010 criteria
2. Treatment naïve participants or participants without current treatment or participants being treated with an approved DMT according to the respective summary of product characteristics (SPC)
Exclusion Criteria
1. Participation in an interventional study or in NIS Confidence (ML39632)
2. Participants not receiving treatment for MS with the studied DMTs according to the standard of care and in line with the current SPC
3. Off-label use of any medication
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants with treatment failure as determined by the occurrence of first confirmed relapse or Expanded Disability Status Scale (EDSS) progression (increase by =1.5 EDSS Points if the initial EDSS is 0, increase by =1.0 EDSS Point if the initial EDSS is =0.5 =5.5, increase by =0.5 EDSS points if the initial EDSS is > 5.5) or magnetic resonance imaging (MRI) activity (new T2 or Gadolinium (Gd) enhancing lesion in spinal or cerebral MRI) or treatment change, whichever occurs first by 48 weeks
- Secondary Outcome Measures
Name Time Method