The TAF-MS study
Key facts
- Where
- Bergen, Drammen, Foerde, Haugesund, Lorenskog, Oslo és Stavanger, NorvégiaSee the 7 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Norvégia
- Helse Bergen HFBergen, NorvégiaNo longer taking part
- Drammen SykehusDrammen, NorvégiaNo longer taking part
- Helse Forde HFFoerde, NorvégiaNo longer taking part
- Helse Fonna HFHaugesund, NorvégiaNo longer taking part
- Akershus University HospitalLorenskog, NorvégiaNo longer taking part
- Oslo University Hospital HFOslo, NorvégiaNo longer taking part
- Helse Stavanger HFStavanger, NorvégiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Helse Bergen HF
- Trial code
- EU 2023-503814-62-00
- Record updated
- 2024. november 8.
- Original description
The objective of the study is to determine the safety of TAF as an add-on therapy to natalizumab.Read full original descriptionShow less
Tenofovir Alafenamide Fumarate and Epstein-Barr virus activity in people with MS – The TAF-MS study
The objective of the study is to determine the safety of TAF as an add-on therapy to natalizumab.
Inclusion: 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).
Exclusion: 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; 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; 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.