Relapsing multiple sclerosis
Conditions
Brief summary
Annualized rate of new or enlarging T2 lesions (AR-NELT2) on MRI at Month 24 (relative to baseline MRI scan).
Detailed description
Participants with no evidence of disease activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6-month confirmed disability progression (6mCDP) and new/enlarging T2 lesions on MRI between baseline and Month 24., Adverse events, laboratory data, vital signs, electrocardiograms (ECGs), (Commercially confidential information)., Extension Part: Adverse events, laboratory data, vital signs, electrocardiogram (ECG), (Commercially confidential information)., Extension Part: - Annualized rate of new or enlarging T2 lesions on MRI - Participants with NEDA-3.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of new or enlarging T2 lesions (AR-NELT2) on MRI at Month 24 (relative to baseline MRI scan). | — |
Secondary
| Measure | Time frame |
|---|---|
| Participants with no evidence of disease activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6-month confirmed disability progression (6mCDP) and new/enlarging T2 lesions on MRI between baseline and Month 24., Adverse events, laboratory data, vital signs, electrocardiograms (ECGs), (Commercially confidential information)., Extension Part: Adverse events, laboratory data, vital signs, electrocardiogram (ECG), (Commercially confidential information)., Extension Part: - Annualized rate of new or enlarging T2 lesions on MRI - Participants with NEDA-3. | — |
Countries
Belgium, Denmark, France, Greece, Italy, Portugal, Slovakia, Spain