Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis

Inclusion Criteria:

Have a relapsing form of multiple sclerosis (RMS; to include RRMS or active secondary progressive MS)
Are willing and able to receive at least 2 lumbar punctures
Have an EDSS of 0 to ≤ 5.5 during the screening period
Had at least 1 relapse or 1 gadolinium-enhancing or 1 new or enlarged T2 lesion in the last 12 months
Have absolute lymphocyte count (ALC) within normal range of the local laboratory or assessed as normal by the investigator within the 3 week screening period and meet all other eligibility criteria for cladribine tablet treatment
Capable of giving signed informed consent

Exclusion Criteria:

Have any contraindication for lumbar puncture
Have current malignancy
Are infected with human immunodeficiency virus (HIV)
Have active chronic infections (e.g. hepatitis or tuberculosis)
Have signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML) in MRI
Have history of hypersensitivity to cladribine or any of the excipients listed in the cladribine tablets US Prescribing Information
Allergy or hypersensitivity to gadolinium and/or any other contraindication to perform a MRI
Have any other comorbid conditions that preclude participation
Have been previously treated with cladribine
Have previously been treated with ocrelizumab, alemtuzumab, rituximab, or daclizumab
Have received treatment with natalizumab during the last 6 months
Are currently receiving immunosuppressive or myelosuppressive therapy, e.g., methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic treatment with systemic corticosteroids
Have received treatment with immunosuppressive or myelosuppressive therapy during the last 6 months
Have received chronic treatment with systemic corticosteroids during the last 4 weeks
Have moderate or severe hepatic impairment (Child-Pugh score >6)
Have moderate or severe renal impairment (creatinine clearance <60 mL per minute)
Are pregnant or unwilling or unable to use effective contraception during cladribine tablets dosing and for 6 months after the last dose in each treatment course
Are intending to breastfeed on a cladribine tablet treatment day and/or during the 10 days after the last cladribine tablet dose.