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Study on Stopping Dimethyl Fumarate and Drug Combination in Patients Aged 55+ with Inactive Relapsing-Remitting Multiple Sclerosis

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What is this trial about?

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

This clinical trial focuses on patients with Multiple Sclerosis (MS), specifically those with a type called Relapsing-Remitting Multiple Sclerosis (RRMS). The study is designed for patients aged 55 and over who have been stable for the past five years. The purpose of the study is to explore whether stopping certain treatments is as effective as continuing them in maintaining a stable condition. The treatments being studied include medications like Tecfidera (also known as dimethyl fumarate), AVONEX (also known as interferon beta-1a), AUBAGIO (also known as teriflunomide), Plegridy (also known as peginterferon beta-1a), Betaferon (also known as recombinant interferon beta-1b), Copaxone (also known as glatiramer acetate), Rebif (also known as interferon beta-1a), and Vumerity (also known as diroximel fumarate).

Participants in the study will be randomly assigned to either continue their current treatment or to stop it. The study will last for about two years, during which time participants will be monitored for any signs of disease activity, such as new symptoms or changes seen on an MRI scan. The study aims to see if stopping treatment is not worse than continuing it in terms of keeping the disease inactive. This could help in deciding the best care for older patients with stable RRMS.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. These check-ups will include assessments of physical abilities and questionnaires about their quality of life. The study will also track any side effects from the treatments. The results could lead to changes in how older patients with stable RRMS are treated, potentially reducing the need for ongoing medication if it is found to be safe and effective to do so.

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
Joining the study
Upon joining the study, the patient is confirmed to be aged 55 or over with a diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald 2017 criteria.
The patient must have experienced their first multiple sclerosis symptom more than 5 years ago and have a stable disease for the last 5 years, as documented by MRI and EDSS scores.
Step 2
Treatment phase
The patient continues or discontinues their current moderate efficacy therapy (MET), which may include medications such as dimethyl fumarate, interferon beta-1a, teriflunomide, diroximel fumarate, or glatiramer acetate.
The treatment phase aims to demonstrate non-inferiority in disease activity-free survival between continuation and discontinuation of treatment.
Step 3
Monitoring and assessments
The patient undergoes regular assessments at months 0, 6, 12, 18, and 24 to monitor disease activity and progression.
Assessments include clinical evaluations, MRI scans, and various tests such as the EDSS, 25-Foot Walk, and 9-Hole Peg Test.
Step 4
Evaluation of endpoints
Primary endpoint: Time to first clinical and/or radiological disease activity is measured over a period of 2 years.
Secondary endpoints include the annual relapse rate, transition to secondary progressive multiple sclerosis, and scores on various questionnaires assessing quality of life and treatment burden.
Step 5
Safety monitoring
Throughout the trial, the safety of treatments is monitored by recording adverse events and conducting clinical examinations and biological analyses if necessary.
The patient is also assessed for multiple sclerosis comorbidities and the economic impact of the treatment.

Who can join the trial?

7 criteria

The patient must be a male or female aged 55 or older.
The patient must have a diagnosis of **RRMS** (Relapsing-Remitting Multiple Sclerosis) based on specific criteria from 2017.
The patient must have experienced their first **MS** (Multiple Sclerosis) symptom more than 5 years ago. If the exact date is unknown, the RRMS diagnosis must have been made more than 5 years ago.
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The patient's disease must have been stable for the last 5 years, which means:
- **Stable T2 lesions**: These are specific areas in the brain or spinal cord that show up on an **MRI** (Magnetic Resonance Imaging) scan. The lesions should not have changed much over the past 5 years.
- **Stable EDSS**: This is a scale used to measure disability in MS. The score should not have changed much over the past 5 years, according to the doctor's judgment.
- No relapses: The patient should not have had any new attacks or worsening of symptoms in the last 5 years.
- The patient must have been treated with a **Moderate Efficacy Therapy (MET)** for at least 5 years in a row. These treatments include medications like IFN-β, glatiramer acetate, dimethyl fumarate, teriflunomide, or diroximel fumarate. Switching from one treatment to another is allowed if it was due to personal preference or intolerance to the first treatment.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with Multiple Sclerosis cannot participate. Multiple Sclerosis is a condition that affects the brain and spinal cord.
Patients under the age of 55 cannot participate. The study is for those aged 55 and over.
Patients who are not considered stable in their condition cannot participate. Stability means their condition is not currently getting worse.
Patients who are part of a vulnerable population cannot participate. This means people who might need extra care or protection.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
CHU Grenoble Alpes
La Tronche, France

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Investigated drugs

Interferon beta
is a medication used to help reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS). It works by modulating the immune system to decrease inflammation and slow the progression of the disease.
Glatiramer acetate
is another treatment option for RRMS. It is designed to mimic a protein in the body and helps to prevent the immune system from attacking the nerves, thereby reducing the number of relapses.
Fingolimod
is an oral medication that helps to reduce the number of relapses in RRMS by preventing certain immune cells from reaching the brain and spinal cord, which helps to reduce inflammation and nerve damage.
Dimethyl fumarate
is a medication taken by mouth that helps to reduce the frequency of relapses in RRMS. It works by activating a pathway in the body that helps protect against inflammation and oxidative stress.
Teriflunomide
is an oral medication used to treat RRMS by reducing the number of active immune cells, which helps to decrease inflammation and the frequency of relapses.
Natalizumab
is a medication given by infusion that helps to reduce the frequency of relapses in RRMS by preventing immune cells from crossing into the brain and spinal cord, thereby reducing inflammation and nerve damage.

What is already known about the treatment

Interferon beta-1a – This medication is administered via injection and is used to treat multiple sclerosis (MS). It is currently well-established in medical practice and literature as a disease-modifying therapy for MS. The main therapeutic indication is to reduce the frequency of relapses and slow the progression of physical disability in patients with relapsing forms of MS. At the molecular level, it works by modulating the immune system to reduce inflammation and prevent nerve damage. It is classified as an immunomodulator.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. Symptoms vary widely and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of the disease can be unpredictable, with periods of remission and relapses. In some cases, it may transition to a more progressive form, leading to increased disability.