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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hospital Foch	Suresnes	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Les Hopitaux De Chartres	Le Coudray	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Groupement Des Hopitaux De L’Institut Catholique De Lille	lomme	France
Centre Hospitalier Intercommunal De Poissy Saint Germain	St Germain En Laye	France
Cagtxi Hkqltfratol Upiomzhemfssz Dv Dwsag	Dijon	France
Alfkrpltvd Pdaldjvu Hqgqfxlu Dr Moyhyjajt	Marseille	France
Cnuzhb Hixyiquzumg Rpiyrhcf Ulamiquorkbiy Dl Tnvho	Tours	France
Ciaout Hawgyzosrcv Rxqfqtda Dyegbrodspcrme	Angers	France
Hoxwlunp Uoudqltbgbxxob Snlcqqrgdh &cuhtmt Hvnefsw dr Hadhwtgdfes	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	24.01.2019

Trial locations

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.

Investigated diseases:

Secondary progressive multiple sclerosis

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 ID:

2024-516628-32-00

Protocol code:

35RC17_8842_STOPISEP

NCT ID:

NCT03653273

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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