Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VigantOL oil plus interferon beta-1a · 1 trial · 1 indication
Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.
| Arm | Type | Description |
|---|---|---|
| VigantOL® oil | EXPERIMENTAL | VigantOL oil plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L |
| Placebo | PLACEBO_COMPARATOR | Placebo daily plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L |
| Rebif | EXPERIMENTAL | Rebif alone in subjects with 25-hydroxy-vitamin D plasma levels equal or higher than 150 nmol/L |
| Name | Type | Description |
|---|---|---|
| VigantOL oil plus interferon beta-1a (Rebif) | DRUG | VigantOL oil 6,670 International Units per day (IU/d) (167 microgram per day \[mcg/day\]), was administered orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) administered orally for 44 weeks on top of Rebif 44mcg three times per week (tiw) administered subcutaneously. |
| Placebo plus interferon beta-1a (Rebif) | DRUG | Matching placebo daily, orally administered matched placebo for 48 weeks on top of Rebif 44 mcg tiw. |
| Interferon beta-1a (Rebif®) alone | BIOLOGICAL | Rebif® 44 mcg tiw, sub-cutaneously alone. |
Inclusion Criteria: * Diagnosis of a relapsing-remitting form of MS * Brain and/or spinal MRI with findings typical of MS * A first clinical event prior to Screening. * Disease activity * Expanded Disability Status Scale (EDSS) score of less than, or equal to 4.0 at Screening. * Currently treated w...