Nervous system diseases
Conditions
Brief summary
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation, Number of Participants with Potentially clinically significant abnormalities (PCSAs
Detailed description
Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies, Annualized Relapse Rate (ARR) for RMS only, Number of new and/or enlarging T2-hyperintense lesions per year, Change from baseline in total volume of T2-hyperintense lesions, ToleDYNAMIC substudy Change from baseline in biomarkers
Interventions
Sponsors
Sanofi-Aventis Research & Development
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation, Number of Participants with Potentially clinically significant abnormalities (PCSAs | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies, Annualized Relapse Rate (ARR) for RMS only, Number of new and/or enlarging T2-hyperintense lesions per year, Change from baseline in total volume of T2-hyperintense lesions, ToleDYNAMIC substudy Change from baseline in biomarkers | — |
Countries
Denmark, Netherlands
Outcome results
None listed