Cladribine for the treatment of secondary progressive MS - randomized, double-blind, placebo-controlled study.

You likely can't join if

• 1. Lack of consent to participate in the study 2. History of cladribine treatment regardless of indication 3. Hypersensitivity to any component of the investigational drug 4. The need to use other immunomodulating or immunosuppressive drugs, including drugs used in secondary progressive MS, e.g. interferon beta-1b, mitoxantrone, siponimod 5. Contraindications for performing magnetic resonance imaging 6. Pregnancy and the period of breastfeeding 7. Lack of consent to the use of effective methods of contraception as defined in the inclusion criteria 8. Diseases of the nervous system (brain or spinal cord tumors, stroke or spinal cord, brain or spinal cord injury, encephalomyelitis, vitamin B12 deficiency, other than multiple sclerosis demyelinating diseases of the central nervous system) 9. Serious accompanying diseases (e.g. cancer, liver and / or kidney failure, heart failure II and III according to NYHA) or other diseases which, in the opinion of the investigator, could threaten the patient's safety in the study or prevent compliance with the requirements of the study protocol 10. Disease relapse <12 months after screening visit 11. Chronic treatment with steroids or immunosuppressants (e.g. azathioprine, methotrexate, cyclosporine) <6 months prior to study entry 12. Disease-modifying therapies: a. Interferons, glatiramer acetate, and dimethyl fumarate must be withdrawn prior to inclusion in the study; they do not require a transition period; b. teriflunomide, fingolimod, natalizumab must be discontinued at least 6 weeks prior to study enrollment; for teriflunomide, the SmPC dropout procedure must be followed if the patient requires enrollment in the study between 2-4 weeks after withdrawal;c. ocrelizumab, mitoxantrone, and alemtuzumab must be discontinued for at least 12 months prior to study enrollment. 13. Relapsing-remitting MS 14. Primary progressive form of MS 15. HBV or HCV infection (positive HBV, positive anti-HBc antibodies or positive anti-HCV antibodies) 16. HIV infection or HIV screening positive (anti-HIV 1/2 antibodies, p24 antigen) 17. Active or latent tuberculosis: a positive QuantiFERON TB Gold (QFT) test during screening or in the 3 months prior to screening (inconclusive test should be repeated; two inconclusive tests are considered positive) 18. Other infections that may worsen with cladribine therapy. 19. Lymphopenia during screening (<1,000 / μl), neutrocytopenia (<1,500 / μl) or thrombocytopenia (<150,000 / μl) 20. Clinical significant abnormalities in the ECG examination according to the researcher's opinion 21. Alcohol or drug abuse in the last 12 months 22. Positive serum pregnancy test during screening 23. History of bone marrow or other organ transplantation 24. Treatment with immunoglobulins or plasmapheresis within the 3 months prior to randomization 25. Treatment with another Investigational medicinal product or medical device in the 6 months prior to randomization 26. At least one abnormal test: a.Creatinine> 1.5 x ULN (ULN; may be repeated if 1.5-2.0 x ULN) b. ALT or AST> 2 x ULN (may be repeated if 1.5-3 x ULN) c. Total Bilirubin> 1.5 x ULN (may be repeated if 1-3 x ULN) d. Hemoglobin <9.5 g / dL (can be repeated if 9-9.4 g / dL) 27. Patient is not fully vaccinated against COVID-19, i.e. at least 6 weeks have not elapsed since the last dose of vaccination. 28. Vaccination with any vaccine within less than 6 weeks 29. The patient has not been screened for neoplasms or the tests performed suggest neoplasm or further tests for neoplasm (chest X-ray PA + side for women and men, mammography or ultrasound of breasts for women, cytology for women, PSA for men). 30. Lack of measurable serum levels of anti-varicella / herpes zoster antibodies. 31. Anticoagulant therapy (oral or parenteral) or anti-platelet therapy other than acetylsalicylic acid.