Clarifying the mechanism of action of cladribine in relapsing multiple sclerosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Signed informed consent form (ICF)
2. Age 18 to 60 years old (inclusive) as of the date the ICF is signed
3. Diagnosis of MS according to the McDonald criteria 2017 and cranial MRI scan demonstrating white matter lesions attributable to MS
4. Therapy with cladribine is indicated (according to label)
5. EDSS score 0.0 to 6.0 (inclusive)
6. Patient did not receive cladribine treatment before and is cladribine treatment naive at time point of inclusion and first blood draw

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Hypersensitivity to the active substance or to any of the excipients of the study medication
2. Acute infection
3. Infection with human immunodeficiency virus (HIV)
4. Active chronic infection (tuberculosis or hepatitis)
5. Suspected progressive multifocal leukoencephalopathy (PML) (a baseline magnetic resonance imaging (MRI) should be performed within 3 months before start of treatment with cladribine)
6. Varicella zoster virus antibody-negative patients
7. Immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy
8. Patients with significant disposition for infections
9. Abnormal lymphocyte count
10. Vaccination with live or attenuated live vaccines within 4 to 6 weeks before start of treatment with cladribine and also during and after cladribine treatment until normalization of white blood cell counts
11. Moderate or severe renal impairment (creatinine clearance <60 mL/min)
12. Patients with impaired liver function (Child-Pugh-Score >6)
13. Patients with active malignancies
14. Patients with hereditary problems of fructose intolerance
15. Pregnancy and breast-feeding
16. For female and male patients of reproductive potential: Unwilling to agree to use a highly effective method of contraception (Pearl index <1) within a period of 6 month after the last cladribine treatment.
17. Medical, psychiatric, cognitive, or other condition that, in the Investigator´s opinion, compromise the patient´s ability to understand the patient information, to give informed consent, or to complete the study
18. Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial resp. 5 half-lives of the previously applied investigational medicinal product depending on which period is longer. Simultaneous inclusion of patients in the clinical trial MAGNIFY (EudraCT-No. 2017-002631-42, Sponsor: Merck KgaA) is permitted. There may be other exceptions at the discretion of the (coordinating) investigator.
19. Therapy with teriflunomide, ozanimod, ponesimod or fingolimod within 4 weeks before start of treatment with cladribine
20. Therapy with natalizumab within 6 weeks before start of treatment with cladribine
21. Therapy with mitoxantron, azathioprin, methotrexat, ciclosporin A or cyclophosphamid within 3 months before start of treatment with cladribine
22. Therapy with alemtuzumab, rituximab or ocrelizumab within 6 months before start of treatment with cladribine

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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