Mulple Sclerosis
Conditions
Interventions
Product Name: Tecfidera
Pharmaceutical Form: Tablet
Sponsors
Department of Neurology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening/Baseline Visit: Patients with relapsing remitting multiple sclerosis (RRMS) fulfilling the McDonald criteria. Treatment-naïve patients and patients treated with first-line disease modifying treatment (DMTs); Age 18-60 years. EDSS 1-5.5. Participants must be able to transport self. Signed 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria Candidates will be excluded from study entry if any of the following exclusion criteria exist at the Screening/Baseline Visit: MS relapse or change in DMT within 60 days. Diagnosis of primary progressive, secondary progressive or progressive relapsing MS. 5 Cancer within five years. ALAT above 90 U/l, BASP above 210 U/l, gamma-GT above 230 U/l. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Screening for a prognostic biomarker regarding MS;Primary end point(s): Finding a prognostic biomarker;Timepoint(s) of evaluation of this end point: 24 months; Secondary Objective: AIM OF THE PHD PROJECT The PhD proposal is centered on three main topics: 1. The examination of biomarkers related to endothelial function/dysfunction in MS with special interest on disease progression and fatigue. 2. The examination of biomarkers related to endothelial function/dysfunction in NMO vs RRMS with special interest on differentiating biomarkers. 3. The effect of DMF on endothelial dysfunction and chronic fatigue in MS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2.2.1. Primary Endpoint The primary endpoint of this study is change from Baseline in the levels of biomarkers reflecting endothelial dysfunction in the serum at Month 24 in subjects with RRMS receiving DMF. 2.2.2. Secondary Objectives The secondary objectives of this study are as follows: 1. Change from Baseline in the levels of biomarkers reflecting endothelial dysfunction in the serum at Month 12 in subjects with RRMS receiving DMF. 3 2. Change from Baseline in the levels of biomarkers reflecting endothelial dysfunction in the CSF at 12 months in subjects with RRMS receiving DMF. 3. Correlation between serum levels of endothelial biomarkers at Baseline and clinical measures of Tecfidera at Months 12 and 24: fatigue, cognition, and function at these timepoints, and relapse rate in the last 2 years before enrolment. 4. The predictive role of serum levels of endothelial biomarkers measured at Baseline on the clinical efficacy of Tecfidera at Months 12 and 24: fatigue, function, relapse rate, and cognition. 5. Correlation between CSF levels of endothelial biomarkers at Baseline and clinical measures of Tecfidera at Months 12: fatigue, cognition, and function at these timepoints, and relapse rate in the last 2 years before enrolment. 6. The predictive role of CSF levels of endothelial biomarkers measured at Baseline on the clinical efficacy of Tecfidera at Months 12 and 24: fatigue, function, relapse rate, and cognition. 8. Correlation between the magnitude of change in endothelial biomarker levels in sera from baseline to Months 12 and 24, and changes in clinical outcomes from basel | — |
Countries
Denmark
Contacts
Public ContactMS clinic, prof Illes
Department of Neurology
Outcome results
None listed