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.
boolean
2. has any progressive form of ms
boolean
3. hypersensitivity to the active substance, or to any of the excipients of lemtrada
boolean
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
boolean
5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms
boolean
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
boolean
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)
boolean
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
boolean
9. history of malignancy, except basal skin cell carcinoma
boolean
10. major psychiatric disorder that is not adequately controlled by treatment
boolean
11. epileptic seizures that are not adequately controlled by treatment
boolean
12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation
boolean
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)
boolean
14. seropositivity for human immunodeficiency virus (hiv)
boolean
15. infection with hepatitis c virus
boolean
16. past or present hepatitis b infection (positive hepatitis b serology)
boolean
17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)
boolean
18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
boolean
19. invasive fungal infections in history and at present
boolean
20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity
boolean
21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication
boolean
22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening
boolean
23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening
boolean
24. b-cell count (absolute cd19+) <lln at screening
boolean
25. absolute neutrophil count <lln at screening
boolean
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
boolean
27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)
boolean
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.
boolean
bilirubin >1.5 × uln
boolean
sgot/ast >3.0 × uln
boolean
sgpt/alt >3.0 × uln
boolean
alkaline phosphatase >2.5 × uln
boolean
creatinine > 1.5 × uln
boolean
29. vaccination less than 6 weeks prior to study inclusion.
boolean
30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion
boolean
31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis
boolean
32. inability to undergo mri with gadolinium administration
boolean
33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating
boolean
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]).
boolean