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

Prior treatment

• 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

Other illness

• Have current malignancy
• Are infected with human immunodeficiency virus (HIV)
• Have active chronic infections (e.g. hepatitis or tuberculosis)
• 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 moderate or severe hepatic impairment (Child-Pugh score \>6)

Lab values

• Have moderate or severe renal impairment (creatinine clearance \<60 mL per minute)

Other

• Have any contraindication for lumbar puncture
• Have signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML) in MRI
• 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.

• 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