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Study of Tenofovir Alafenamide as Add-on Treatment to Anti-CD20 Therapy in Multiple Sclerosis Patients to Reduce Neuronal Damage

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Multiple Sclerosis, a condition that affects the nervous system. The research examines whether adding Tenofovir Alafenamide Fumarate (TAF) to existing anti-CD20 therapy can help reduce nerve damage in people with multiple sclerosis. The study specifically targets the Epstein-Barr Virus, which may play a role in the disease process.

During the study, participants will receive either Tenofovir Alafenamide Fumarate or placebo in addition to their regular multiple sclerosis treatment. The medication or placebo will be given as oral capsules over a period of 52 weeks. This is a double-blinded study, which means neither the participants nor the healthcare providers will know who receives the actual medication.

The research aims to determine if this combination treatment approach is more effective at protecting nerve cells compared to standard treatment alone. Throughout the study, various tests will be performed to monitor the participants' response to treatment, including examination of spinal fluid and brain imaging. The study will also track how well patients tolerate the treatment and monitor any changes in their fatigue levels.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your participation begins with confirming that you have multiple sclerosis diagnosed according to McDonald criteria.
Medical tests will be performed to verify your eligibility, including blood tests for EBV antibodies, liver function, kidney function, and screening for HIV and hepatitis.
A brain scan (MRI) will be performed to measure lesion volume.
Step 2
Treatment assignment
You will be randomly assigned to receive either Tenofovir Alafenamide Fumarate or a placebo (inactive capsule).
This is a double-blind study, meaning neither you nor your doctor will know which treatment you are receiving.
You will continue your current anti-CD20 therapy throughout the study.
Step 3
Treatment period
The treatment period lasts for 52 weeks (1 year).
You will take the study medication orally as prescribed.
Regular medical assessments will be conducted to monitor your health throughout the study.
Step 4
Medical procedures
You will undergo two lumbar punctures (spinal fluid collection) - one at the start and one at the end of the study.
Two imaging sessions (MRI and PET scans) will be performed in Turku, Finland - at the beginning and end of the study.
Your fatigue levels will be monitored through questionnaires.
Step 5
Study completion
Final medical evaluations will be performed at week 52.
The study will measure changes in your neurofilament light chain levels (a marker of nerve damage) and other indicators of disease activity.
Your participation in the study will end after completing all final assessments.

Who can join the trial?

15 criteria

Age between 18 and 70 years old
Diagnosed with Multiple Sclerosis according to McDonald criteria
EDSS score (a scale that measures disability in multiple sclerosis) between 2.0 and 6.5
Brain MRI showing at least 15.00 cm3 of areas affected by the disease
Positive for Epstein-Barr virus (EBV) antibodies in blood
White blood cell count above 1.5 x 109/L
Platelet count above 50 x 109/L
Liver function test (ALAT) less than 2 times the normal upper limit
Blood creatinine (kidney function test) less than 200 µmol/L
Kidney function (creatinine clearance) above 15 ml/min
Blood bilirubin less than 2 times the normal upper limit
Negative tests for HIV, hepatitis B, and hepatitis C
Previous treatment with rituximab (an antibody therapy) for at least 24 months
Women must use effective contraception
Ability to undergo lumbar puncture (spinal tap) and travel for MRI and PET imaging

Who cannot join the trial?

14 criteria

Age below 18 or above 65 years
Known allergies or hypersensitivity to anti-CD20 therapy (a type of medication that affects immune system cells)
Pregnancy or breastfeeding
Other neurological conditions besides multiple sclerosis
Participation in other clinical trials within the past 30 days
Serious heart, liver, or kidney disease
Active infections or compromised immune system
History of cancer in the past 5 years
Unable to undergo MRI scans (magnetic resonance imaging - a type of medical imaging)
Use of medications that could interfere with the study treatment
Inability to provide informed consent
History of drug or alcohol abuse within the past year
Psychiatric conditions that could interfere with study participation
Unstable medical conditions that could affect safety during the trial

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Akershus University Hospital
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Lorenskog, Norway
Helse Bergen HF
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Bergen, Norway
Oslo Universitetssykehus HF
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Oslo, Norway

Trial locations

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Investigated drugs

Tenofovir Alafenamide Fumarate (TAF)
is an antiviral medication typically used to treat viral infections. In this trial, it is being studied as an additional treatment for multiple sclerosis, specifically targeting the Epstein-Barr virus. The medication is being tested to see if it can help reduce nerve damage when used alongside other MS treatments.
Anti-CD20 therapy
is a type of treatment that targets specific immune cells (B-cells) in the body. It is a standard treatment for multiple sclerosis that helps control the immune system's response and reduce inflammation that can damage the nervous system. In this trial, all participants receive this therapy as their base treatment.

Tenofovir Alafenamide

What is already known about the treatment

Tenofovir Alafenamide Fumarate (TAF) – An oral antiviral medication that belongs to the class of nucleotide reverse transcriptase inhibitors, primarily used in treating viral infections and being investigated for multiple sclerosis treatment. The drug works by interfering with viral DNA replication, particularly targeting the Epstein-Barr virus, which has been associated with multiple sclerosis development. Currently being studied in clinical trials as an add-on therapy to anti-CD20 treatments for multiple sclerosis patients, TAF shows promise in potentially reducing neuronal damage through its antiviral properties. The medication is administered in tablet form and has shown a better safety profile compared to earlier tenofovir formulations due to its enhanced delivery to target cells.

Investigated diseases

Multiple Sclerosis - A chronic disease affecting the central nervous system, where the immune system attacks the protective covering of nerve fibers (myelin). The damage disrupts communication between the brain and the rest of the body, leading to various neurological symptoms. The disease typically progresses with periods of relapse and remission, during which symptoms may appear and then improve. Symptoms can include fatigue, difficulty walking, vision problems, numbness or tingling in different parts of the body, and problems with coordination and balance. The condition varies significantly from person to person, with different patterns of progression and symptom manifestation.