multiple sclerosis
Conditions
Interventions
None listed
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In short, the only inclusion criteria are: i) matching the inclusion criteria of SOLAR, ii) willing to provide additional informed consent for the SOLAR(IUM) study. The inclusion most prominent criteria of SOLAR are: • Males and females between 18 and 50 years of age. • Diagnosis of a relapsing-remitting form of MS, according to the revised McDonald criteria 2005 • Brain and/or spinal MRI with findings typical of MS. • A first clinical event occurring within 5 years prior to Screening. • Disease activity characterized by: at least one MS lesion within the 12 months prior to Screening, or ne or more Gd-enhancing MRI lesions within the 12 months prior to Screening. • EDSS score
Exclusion criteria
Exclusion criteria: Te only exclusion criterion of SOLAR(IUM) is matching any exclusion criterium of SOLAR. The most prominent exclusion criteria of SOLAR are: • 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. • Use of any cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure within 12 months prior to Screening. • Use of oral or systemic corticosteroids or ACTH within 30 days prior to the SD1 visit. • 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 (11 mg/100cc (5.5 mEq./l.). • Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides. • Are taking more than 400 IU (10 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, defined by alanine aminotransferase (ALT) > 3 times upper limit of normal (ULN), aspartate aminotransferase (AST) > 3 times upper limit of normal (ULN)or alkaline phosphatase > 2.5 times ULN, or total bilirubin > 1.5 times ULN, if associated with any elevation of ALT or alkaline phosphatase • Moderate to severe renal impairment • Inadequate bone marrow reserve, defined by a WBC count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Difference in distribution of cytokine profile of peripheral CD4+ T lymphocytes by flowcytometry at Week 48 between treatment arms | — |
Secondary
| Measure | Time frame |
|---|---|
| • Difference in distribution of results from phenotypic analysis of T and B lymphocyte subsets by flowcytometry at Week 48 and Week 96 between treatment arms; • Difference in distribution of results from functional analysis of cytokine production (flowcytometry and ELISA assays) by T and B lymphocytes at Week 48 and Week 96 between treatment arms; • Differences in distribution of circulating levels of immune-related regulatory molecules at Week 48 and 96 between treatment arms; • Difference in evolution in time of immune-parameters described above between the treatment arms; • Correlation of the distribution of results from the analyses above with serum levels of 25-hydroxyvitamin D in all participants, as are collected in the SOLAR(IUM) study; • Difference in distribution of results from the analyses above between patients from the vitamin D3 supplementation arm which did or did not respond clinically to vitamin D3 supplementation (i.e. remained relapse free in the SOLAR trial at week 96/ No signs of disease activity on MRI); • Difference in distribution of results from the analyses above between carriers of relevant genetic polymorphisms as are studied in the SOLAR trial, including MHC class II region (HLA-DRB15*01) and the vitamin D metabolism genes (VDR and CYP27B1). | — |
Countries
Netherlands
Outcome results
None listed