Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential; ODM derived from: Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany



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September 27, 2021


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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

Inclusion Criteria
1. signed informed consent form (icf)
2. age 18 to 55 years old (inclusive) as of the date the icf is signed
3. diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before screening
4. onset of ms symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the icf is signed
5. edss score 0.0 to 4.0 (inclusive) at screening
6. ≥2 ms relapses within 24 months or clinical (≥1 relapse) or mri (new gadolinium enhancing lesions) disease activity under therapy with interferon beta, glatirameracetate, natalizumab or fingolimod
7. indicated to receive alemtuzumab according to the investigator's assessment
8. completion of all vaccinations required by the applicable immunization guidelines published by "ständige impfkommission" (stiko)
9. history of chickenpox or positive test for antibodies against varicella zoster virus (vzv)
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.
2. has any progressive form of ms
3. hypersensitivity to the active substance, or to any of the excipients of lemtrada
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
5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms
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
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)
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
9. history of malignancy, except basal skin cell carcinoma
10. major psychiatric disorder that is not adequately controlled by treatment
11. epileptic seizures that are not adequately controlled by treatment
12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation
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)
14. seropositivity for human immunodeficiency virus (hiv)
15. infection with hepatitis c virus
16. past or present hepatitis b infection (positive hepatitis b serology)
17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)
18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
19. invasive fungal infections in history and at present
20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity
21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication
22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening
23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening
24. b-cell count (absolute cd19+) <lln at screening
25. absolute neutrophil count <lln at screening
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
27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)
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.
bilirubin >1.5 × uln
sgot/ast >3.0 × uln
sgpt/alt >3.0 × uln
alkaline phosphatase >2.5 × uln
creatinine > 1.5 × uln
29. vaccination less than 6 weeks prior to study inclusion.
30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion
31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis
32. inability to undergo mri with gadolinium administration
33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating
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]).

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