Tecfidera induced lymphocytopenia
Conditions
Interventions
None
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: MS patients 1. male and female subjects; 2. minimal age 18 years at the time of informed consent; 3. confirmed relapsing remitting multiple sclerosis (RRMS) patients, with: i. a diagnosis of RRMS according to the revised McDonald criteria; ii. a baseline score of 0 to 5.0 on the Expanded Disability Status Scale; 4. patients on Tecfidera treatment for at least 6 months; 5. ability to participate, and willingness to give written informed consent and to comply with the study restrictions and protocol requirements. Healthy subjects 1. healthy male and female subjects; 2. minimal age of 18 years at the time of informed consent; 3. ability to participate, and willingness to give written informed consent and to comply with the study restrictions and protocol requirements.
Exclusion criteria
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; 2. evidence of any active or chronic disease or condition, other than MS (based on medical history, a physical examination, vital signs, 12 lead ECG, haematology, blood chemistry and urinalysis) that could, in the opinion of the investigator, interfere with the conduct of the study or the study objectives, or pose an unacceptable risk to the subject; 3. a treatment history that includes steroids within one month prior to screening, or any other therapy that in the judgment of the investigator potentially interferes with the study objectives (in case of an insufficient washout period); 4. body weight < 50 kg. 5. subject is pregnant or breast feeding; 6. current substance abuse, including alcohol and drugs; 7. positive alcohol test or test for drugs of abuse at screening, with the exception of a positive test due to medicinal cannabis use; 8. previous deuterium administration; 9. participation in an investigational drug or device study within 3 months prior to screening; 10. loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening; 11. unwillingness or inability to comply with the study protocol for any other reason. Healthy subjects 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; 2. evidence of any active or chronic disease or condition (based on medical history, a physical examination, vital signs, 12 lead ECG, haematology, blood chemistry and urinalysis) that could, in the opinion of the investigator, interfere with the conduct of the study or the study objectives, or pose an unacceptable risk to the subjects; 3. a treatment history that includes steroids within 1 months prior to screening, or any other therapy that in the judgment of the investigator potentially interferes with the study objectives (in case of an insufficient washout period); 4. body weight < 50 kg; 5. subject is pregnant or breast feeding; 6. current substance abuse, including alcohol and drugs; 7. positive alcohol test or test for drugs of abuse at screening; 8. previous deuterium administration; 9. participation in an investigational drug or device study within 3 months prior to screening; 10. loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening; 11. unwillingness or inability to comply with the study protocol for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives: 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; 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; 3.Assessment of markers for cell death and cellular stress, in relation to cell production and disappearance rates. | — |
Contacts
Public ContactCentre for Human Drug Research
Zernikedreef 8
Outcome results
None listed