Relapsing multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Cohort 1: Participants with multiple sclerosis (MS) disease activity on any disease-modifying therapy (DMT) in the past 12 months.
Cohort 2: Participants with significant adverse drug reactions of DM
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Time to first confirmed relapse during the study (up to 12 months). A relapse is defined as an episode of neurological symptoms that happens at least 30 days after any previous episode began, lasts at least 24 hours and is not attributable to another cause and occurs in the absence of an infection or fever. Changes in neurological examination or an increase in the EDSS Score after confirmation by the treating physician is defined as a confirmed relapse. 2. Percentage of relapse-free participants at the end of study (month 12) where relapse is defined as an episode of neurological symptoms that happens at least 30 days after any previous episode began, lasts at least 24 hours and is not attributable to another cause and occurs in the absence of an infection or fever., and is confirmed by the treating physician through e.g. changes in neurological examination or an increase in the EDSS score the relapse is called a confirmed relapse 3. Change from Baseline in measure of disability and disease progression using the EDSS score around months 6 and 12 4. Time to EDSS progression during the study (up to 12 months). EDSS progression is defined as an increase by =1.5 EDSS points if the initial EDSS is 0, increase by =1.0 EDSS points if the initial EDSS is = 0.5 = 5.5, increase by =0.5 EDSS points if the initial EDSS is >5.5 5. Percentage of participants with treatment change and the type of treatments from baseline up to month 12. Treatment change is defined as any change of the actual treatment status at baseline i.e., due to ongoing disease activity, actual or theoretical safety concerns, low treatment satisfaction, or low quality of life (Qol) 6. Change from Baseline in global impression on the disease course measured using the adapted Clinical Global Impression (CGI) as reported by participant and physician around months 6 and 12 7. Change from baseline in quality of life and participant-reported treatment satisfaction as measured by Health-Related Quality of Life (HR | — |
Countries
Germany
Contacts
Public ContactMedical Information
Outcome results
None listed