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The TAF-MS study
EU CTIS ID: 2023-503814-62-00
What this study is testing
The objective of the study is to determine the safety of TAF as an add-on therapy to natalizumab.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 18 to ≤ 70 years, both male and female patients
- 2. Diagnosis of RRMS using revised McDonald criteria of clinically definite MS.1
- 3. Currently treated with natalizumab
- 4. Demonstrated shedding of EBV in salvia (Shedding is defined as at least one salvia sample with >5.8 virus copies/µL cut-off)
You likely can't join if
- 1. Known hypersensitivity or other serious adverse reaction to the active agent or other component of the study medication.
- 4. History of pancreatitis
- 5. 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
- 6. Current users of medications that could interact with the study medication (listed in paragraph 5.6)
- 7. Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT)
- 8. 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.
See the full eligibility criteria
- 1. Age ≥ 18 to ≤ 70 years, both male and female patients
- 2. Diagnosis of RRMS using revised McDonald criteria of clinically definite MS.1
- 3. Currently treated with natalizumab
- 4. Demonstrated shedding of EBV in salvia (Shedding is defined as at least one salvia sample with >5.8 virus copies/µL cut-off)
- 1. Known hypersensitivity or other serious adverse reaction to the active agent or other component of the study medication.
- 4. History of pancreatitis
- 5. 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
- 6. Current users of medications that could interact with the study medication (listed in paragraph 5.6)
- 7. Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT)
- 8. 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.
- 9. Platelet (thrombocyte) count < 100 x 109 /L
- Creatinin clearance < 15 ml/min
- 10. ALAT more than 2 times the upper normal reference limit (ULN)
- 11. Serum creatinine > 200 µmol/L
- 12. Serum bilirubin > 2 times the ULN
- 13. Any other disease that can influence the patient safety and compliance, or the evaluation of outcome
- 14. Currently enrolled in other trials of an investigational drug, or less than 30 days since ending another investigational drug.
- 15. 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
- 2. Women who are pregnant, as verified by a serum pregnancy test at screening and during follow-up, or lactating
- 3. Any ongoing infection with HIV, chronic active hepatitis, hepatitis C, or hepatitis B surface antigen positivity
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.