Multiple Sclerosis
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria *Disease duration of 10 years or less *At least one relapse in the last year *EDSS score 0 to 5.0 at entry
Exclusion criteria
Exclusion criteria: *Active chronic disease of the immune system other than multiple sclerosis *History of malignancy within the past 5 years *Active systemic bacterial, viral or fungal infections *Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s) *Any medically unstable condition *Unable to undergo MRI scans or repeated blood tests *Pregnant or nursing females *Women of child-bearing potential must use reliable forms of contraception *Other protocol-defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative number of new Gadolinium [Gd]-enhancing T1-weighted lesions [ Time Frame: Months 3, 4, 5, 6 ] Primary endpoint is the cumulative number of new Gd-enhancing T1-weighted lesions seen on brain MRI scans obtained at Months 3, 4, 5 and 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized relapse rate [ Time Frame: 6 Months ] Annualized relapse rate is total number of relapses divided by total number of days on study, multiplied by 365.25 to obtain the annual rate. Combined unique active lesions (CUAL) [ Time Frame: Months 3, 4, 5, 6 ] New Gd-enhancing T1-weighted lesions or new/enlarging T2-weighted lesions avoiding double counting. Change in total volume of T2-weighted lesions [ Time Frame: Baseline, Month 6 ] Mean change in total volume of T2-weighted lesions at Month 6. Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Baseline to Month 6 ] All AE/SAE will be reported in safety section of record. | — |
Outcome results
None listed