Characterization immuno-modulatory effects of Tecfidera: feasibility study.
Recruiting
- Conditions
- Tecfidera induced lymphocytopenia
- Registration Number
- NL-OMON27762
- Lead Sponsor
- ot Applicable
- Brief Summary
ot Applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
MS patients
1.male and female subjects;
Exclusion Criteria
MS patients
1.positive test result for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), anti HB core and/or hepatitis B surface antigen (HbsAg) at screening;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objectives:<br /><br>1.Quantification of CD4+, naive and memory CD8+ T-cell and CD19+ B-cell numbers in Tecfidera-treated MS patients and untreated healthy subjects over time;<br /><br>2.Quantification of production and disappearance rates of CD4+, naive and memory CD8+ T-cells and CD19+ B-cells in Tecfidera-treated MS patients and untreated healthy subjects;<br /><br>3.Assessment of markers for cell death and cellular stress, in relation to cell production and disappearance rates.<br>
- Secondary Outcome Measures
Name Time Method ot Applicable