Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Stopping Disease-Modifying Therapies in Inactive Secondary Progressive Multiple Sclerosis Patients Over 50 Using Glatiramer Acetate and Drug Combination

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial focuses on studying the effects of stopping certain treatments in patients with a type of multiple sclerosis known as Secondary Progressive Multiple Sclerosis (SPMS). SPMS is a stage of multiple sclerosis where the disease gradually worsens over time. The study involves patients who are 50 years or older and have not shown recent signs of active disease, such as new symptoms or changes seen on an MRI scan, for at least three years. The treatments being studied include medications like Glatiramer Acetate, Cyclophosphamide, Interferon Beta-1A, Interferon Beta-1B, Mycophenolate Mofetil, Ocrelizumab, Rituximab, Teriflunomide, Dimethyl Fumarate, Azathioprine, and Methotrexate.

The purpose of the study is to see if stopping these treatments is not worse than continuing them in terms of how the disease progresses over two years. Participants will be divided into two groups: one group will stop their current treatment, and the other will continue. The study will monitor changes in disability, which refers to difficulties in physical activities, over the two-year period. This will help determine if stopping the treatment affects the progression of the disease.

Throughout the study, participants will have regular check-ups to assess their condition. These check-ups will include tests to measure physical abilities and brain scans to look for any changes. The study will also track any relapses, which are periods when symptoms suddenly get worse, and overall quality of life. The goal is to understand if stopping treatment is a safe option for patients with inactive SPMS who are older than 50 years.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the clinical trial, an initial assessment is conducted to confirm eligibility. This involves reviewing medical history and current health status to ensure all criteria are met.

    The assessment includes a review of the Expanded Disability Status Scale (EDSS) score, which measures disability in multiple sclerosis. A score of 3 or higher is required.

  2. Step 2

    Treatment allocation

    Participants are assigned to either continue their current disease-modifying therapy (DMT) or to withdraw from it. This decision is based on the study's design to compare outcomes between these two groups.

    The therapies involved may include medications such as glatiramer acetate, interferon beta-1a, teriflunomide, and others, depending on the participant's prior treatment.

  3. Step 3

    Regular monitoring

    Participants undergo regular monitoring throughout the trial. This includes clinical visits to assess health status and any changes in symptoms.

    Monitoring involves periodic MRI scans to check for new or enlarging brain lesions and to assess brain volume changes.

  4. Step 4

    Disability assessment

    Disability progression is evaluated at regular intervals. This involves checking for any increase in the EDSS score or changes in the ability to perform specific tasks, such as walking or using hands.

    The primary goal is to determine if there is any progression in disability over the two-year period.

  5. Step 5

    Quality of life evaluation

    Participants complete questionnaires to assess quality of life. These include the SEP-59 and EuroQOL EQ-5D scores, which measure various aspects of daily living and well-being.

    Changes in these scores from the start to the end of the trial are analyzed to understand the impact of treatment withdrawal or continuation.

  6. Step 6

    Final assessment

    At the end of the two-year trial period, a final assessment is conducted. This includes a comprehensive review of all health data collected during the study.

    The final assessment aims to determine the overall impact of continuing or withdrawing from DMT on disability progression and quality of life.

Who can join the trial?

5 criteria

  • Patients must be 50 years old or older.
  • Must have had a secondary progressive form of Multiple Sclerosis for at least 3 years. This means their condition has been getting worse over time, not because of relapses, with an increase of at least 1 point on the EDSS scale since the progressive phase started. If their EDSS score is 5.5 or higher, an increase of 0.5 points is enough. The EDSS scale is a way to measure disability in people with Multiple Sclerosis.
  • Must have been on a disease-modifying therapy (DMT) for Multiple Sclerosis for at least 3 years. This includes treatments like interferon, glatiramer acetate, teriflunomide, dimethyl fumarate, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, rituximab, or ocrelizumab. Patients who have switched between these treatments during the 3 years can also participate. However, they should not have been treated with fingolimod or natalizumab in the year before joining the study.
  • There should be no evidence of active inflammation in the brain for at least 3 years. This means no new symptoms or changes seen on an MRI scan with a special dye called gadolinium.
  • Must have an EDSS score of 3 or higher.

Who cannot join the trial?

2 criteria

  • Patients who have had a **clinical relapse** (a return of symptoms) or **radiological activity** (changes seen in medical imaging) in the last 3 years cannot participate.
  • Patients who are not classified as having **inactive** Secondary Progressive Multiple Sclerosis (SPMS) according to the Lublin classification are excluded. This means they must not have shown recent evidence of focal inflammatory activity for at least 3 years.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Disease Modifying Therapies (DMTs) are treatments used to slow down the progression of multiple sclerosis (MS). In this clinical trial, the focus is on patients with Secondary Progressive Multiple Sclerosis (SPMS) who are older than 50 years and have not shown recent signs of active inflammation. The trial is investigating whether stopping these therapies is as effective as continuing them in terms of preventing further disability over two years. DMTs work by targeting the immune system to reduce the frequency and severity of MS attacks and to slow the progression of the disease.

What is already known about the treatment

Disease Modifying Therapies (DMTs) – DMTs are typically administered orally, by injection, or infusion, depending on the specific medication. They are currently used in the treatment of Multiple Sclerosis (MS) and are well-documented in medical literature. The main therapeutic indication for DMTs is to manage and slow the progression of MS, particularly in patients with Secondary Progressive Multiple Sclerosis (SPMS). At the molecular level, DMTs work by modulating the immune system to reduce inflammation and prevent damage to the nervous system. They are classified pharmacologically as immunomodulatory agents.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis is a chronic disease affecting 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. The progression of the disease can vary widely among individuals, with some experiencing mild symptoms and others facing severe disability. Symptoms may include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The disease often progresses in a pattern of relapses and remissions, but some individuals may experience a gradual worsening of symptoms over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516628-32-00Protocol code35RC17_8842_STOPISEPEstimated enrolment250 patientsSponsorCentre Hospitalier Universitaire De Rennes

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).