HiHat trial

Prior treatment

• No prior exposure to varicella virus. This is assessed through varicella serology.
• Vaccination within 4 weeks of first dose of study medication
• Previous use of rituximab (or any other B-dell depleting monoclonal antibody) and/or cladribine
• Simultaneous treatment with other immunosuppressive drugs.

Other illness

• Active malignancy
• Severe psychiatric condition.
• Infection with human immunodeficiency virus (HIV)
• Severe cardiac disorder. E.g. signs of congestive heart failure or coronary artery disease. This will be evaluated through clinical assessment before inclusion.

Lab values

• Moderate or severe renal impairment. Estimated glomerular filtration rate (eGFR) <60.
• Active, severe infections (e.g. hepatitis or tuberculosis). Signs of infections are assessed before inclusion and each study-related infusion through clinical examination and further evaluated by laboratory and other relevant investigations in case of suspected ongoing infection.

Other

• Diagnosis of progressive MS.
• Pregnant or lactating women, s-HCG will be tested on all women at screening and in any situation where there is a reason to suspect pregnancy during the trial, e.g. delayed menstruation.
• Unwilling to use contraception during the treatment period and the first year after completing the treatment course.
• Patients having contraindication for or otherwise not compliant with MRI investigations.

• Diagnosis of RRMS according to the 2017 revised McDonald criteria.
• Disease activity within the preceding year in the form of: (a) a clinical relapse, and/or (b) evidence of ≥2 T2 lesions on MRI scan, and or (c) presence of gadolinium enhancing lesions on an MRI scan
• Age 18 – 50 years (inclusive) of age
• Disease duration ≤10 years (since MS diagnosis)
• EDSS 0 – 5.5 (inclusive)
• Signed informed consent