Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378 Inclusion Criteria Exclusion Criteria 1. participation in another clinical trial at present or within 4 weeks of study entry. there may be exceptions at the discretion of the investigator. Yes
No
2. has any progressive form of ms Yes
No
3. hypersensitivity to the active substance, or to any of the excipients of lemtrada Yes
No
4. medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study Yes
No
5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms Yes
No
6. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage Yes
No
7. known bleeding disorder (e.g,. dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation (dic), fibrinogen deficiency, or clotting factor deficiency) Yes
No
8. significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis Yes
No
9. history of malignancy, except basal skin cell carcinoma Yes
No
10. major psychiatric disorder that is not adequately controlled by treatment Yes
No
11. epileptic seizures that are not adequately controlled by treatment Yes
No
12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation Yes
No
13. in the investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection) Yes
No
14. seropositivity for human immunodeficiency virus (hiv) Yes
No
15. infection with hepatitis c virus Yes
No
16. past or present hepatitis b infection (positive hepatitis b serology) Yes
No
17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv) Yes
No
18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis. Yes
No
19. invasive fungal infections in history and at present Yes
No
20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity Yes
No
21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication Yes
No
22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening Yes
No
23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening Yes
No
24. b-cell count (absolute cd19+) <lln at screening Yes
No
25. absolute neutrophil count <lln at screening Yes
No
26. confirmed platelet count < the lln of the evaluating laboratory at screening or documented at <100,000/μl within the past year on a sample without platelet clumping Yes
No
27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo) Yes
No
28. any hepatic or renal function value grade 2 or higher at screening, with the exception of hyperbilirubinemia due to gilbert's syndrome. see table below, drawn from the national cancer institute (nci) common terminology criteria for adverse events v4.0 (ctcae), published 28 may 2009. Yes
No
bilirubin >1.5 × uln Yes
No
sgot/ast >3.0 × uln Yes
No
sgpt/alt >3.0 × uln Yes
No
alkaline phosphatase >2.5 × uln Yes
No
creatinine > 1.5 × uln Yes
No
29. vaccination less than 6 weeks prior to study inclusion. Yes
No
30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion Yes
No
31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis Yes
No
32. inability to undergo mri with gadolinium administration Yes
No
33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating Yes
No
34. female patients of childbearing potential: unwilling to agree to use a reliable and acceptable contraceptive method (pearl index <1) throughout the study period. these methods include: hormone releasing intrauterine device (iud), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]). Yes
No
