The TAF-MS study

Prior treatment

• Prior or current disorders influencing the patient’s ability to give an informed consent or to comply with treatment and follow-up of the protocol
• Current users of medications that could interact with the study medication (listed in paragraph 5.6)
• Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT)
• Currently enrolled in other trials of an investigational drug, or less than 30 days since ending another investigational drug.

Other illness

• Known hypersensitivity or other serious adverse reaction to the active agent or other component of the study medication.
• History of pancreatitis
• Any other disease that can influence the patient safety and compliance, or the evaluation of outcome
• Contraindications to undergo MRI such as a history of claustrophobia, inability to lie flat for approximately one hour, or metal implants (metal pins or plates, extensive non-removable dental work, cerebral aneurysm clips, pacemaker) as assessed by a standardized screening form
• Any ongoing infection with HIV, chronic active hepatitis, hepatitis C, or hepatitis B surface antigen positivity

Lab values

• WBC < 1.5 x 109 /L if not caused by a reversible effect of documented ongoing medication. If WBC < 1.5 x 109 /L is caused by a reversible effect of documented ongoing medication the WBC count must be > 1,5 x 109 /L before start of study treatment.
• Platelet (thrombocyte) count < 100 x 109 /L
  • Creatinin clearance < 15 ml/min
• ALAT more than 2 times the upper normal reference limit (ULN)
• Serum creatinine > 200 µmol/L
• Serum bilirubin > 2 times the ULN
• Women who are pregnant, as verified by a serum pregnancy test at screening and during follow-up, or lactating

• Age ≥ 18 to ≤ 70 years, both male and female patients
• Diagnosis of RRMS using revised McDonald criteria of clinically definite MS.1
• Currently treated with natalizumab
• Demonstrated shedding of EBV in salvia (Shedding is defined as at least one salvia sample with >5.8 virus copies/µL cut-off)