Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.

Phase 1

• Conditions: Relapsing-Remitting Multiple Sclerosis; MedDRA version: 14.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-020328-23-PT
• Lead Sponsor: Merck Serono SA - Geneva, an affiliate of Merck KGaA,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-17
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 358

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
•EDSS score of less than, or equal to 4.0 at Screening.
•Currently treated with interferon-beta-1a 44µg (tiw) sc
•Willingness and ability to comply with the protocol
•Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 358
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnancy and lactation period
•Any disease other than MS that could better explain signs and
symptoms.
•Complete transverse myelitis or bilateral optic neuritis.
•Currently receiving or use at any time of monoclonal antibodies,
mitoxantrone, cytotoxic or immunosuppressive therapy (excluding
systemic steroids and adrenocorticotrophic hormone [ACTH]), B cell modulating therapies (e.g. RituxiMab or BelimuMab), total lymphoid irradiation or bone marrow transplantation.
•Use of any cytokine (other than interferon) or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure
•Use of oral or systemic corticosteroids or ACTH
•Have experienced a relapse within 30 days before the SD1 visit
•Have abnormalities of Vitamin D related hormonal system other than low dietary intake or decreased sun exposure, i.e. primary
hyperparathyroidism or granulomatous disorders.
•Have an urine calcium/creatinine (mmol/mmol) ratio greater than 1.0 or hypercalcaemia
•Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides.
•Are taking more than 1000 IU (25 µg) of Vitamin D supplement daily.
•Have conditions with increased susceptibility to hypercalcaemia, e.g., known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide and those who suffer from nephrolithiasis.
•Have inadequate liver function
•Moderate to severe renal impairment
•Inadequate bone marrow reserve
•History or presence of serious or acute heart disease such as
uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4).
•History or presence of severe depression, history of suicide attempt, or current suicidal ideation.
•Epilepsy or seizures not adequately controlled by treatment.
•Current or past alcohol or drug abuse.
•Any major medical or psychiatric illness (such as psychosis, bipolar disorder) that in the opinion of the Investigator could create undue risk to the subject or could affect adherence with the trial protocol.
•Known contra-indication to treatment with vitamin D
•Known hypersensitivity to interferon or its excipient(s)
•Known hypersensitivity to gadolinium.
•Any other condition that would prevent the subject from undergoing an MRI scan.
•Signs and symptoms suggestive of transmissible spongiform
encephalopathy, or family members who suffer(ed) from such.
•Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody)
serology (test performed at screening).
•Legal incapacity or limited legal capacity.
•Another current autoimmune disease, except diabetes.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of Vigantol® oil versus placebo as add-on therapy<br>in subjects with Relapsing-Remitting Multiple Sclerosis receiving<br>treatment with Rebif®.;Secondary Objective: • To assess changes on clinical parameters.<br>• To assess changes in MRI parameters.<br>• To investigate the safety profile up to the end of the Treatment Period (Week 96),<br>• To explore pharmacogenetics (PGx), gene expression and circulating biomarkers and to evaluate whether there is a possible relationship to Vigantol® oil treatment outcomes.;Primary end point(s): •Mean number of CUA lesions at week 48<br>•Proportion of relapse-free subjects at week 96;Timepoint(s) of evaluation of this end point: •Mean number of CUA lesions at week 48<br>•Proportion of relapse-free subjects at week 96