Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis Rebif VigantOL® oil Vitamin D Add-on treatment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: no

Brief summary:
The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of patients with Multiple Sclerosis have Vitamin D deficiency.

Rebif® is known to be an effective treatment for slowing down the progression of MS. The purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any benefit on the progression of MS compared to Rebif® and placebo.

Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging (MRI). The planned study treatment duration for each study participant is 48 weeks, and the study consists of a total of 8 visits. Study participants who are already passed Week 48 at the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a total of 12 visits.

During the study, the participant will undergo physical examination, neurological assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).

Detailed description:

Arms:
arm 1: VigantOL oil plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L arm 2: Placebo daily plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L arm 3: Rebif alone in subjects with 25-hydroxy-vitamin D plasma levels equal or higher than 150 nmol/L

Interventions: intervention 1: VigantOL oil plus interferon beta-1a (Rebif) intervention 2: Placebo plus interferon beta-1a (Rebif) intervention 3: Interferon beta-1a (Rebif®) alone
Intervention descriptions: intervention 1: 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. intervention 2: Matching placebo daily, orally administered matched placebo for 48 weeks on top of Rebif 44 mcg tiw. intervention 3: Rebif® 44 mcg tiw, sub-cutaneously alone.

Protocol document: