Study on the Effectiveness and Safety of Ocrelizumab for Patients with Progressive Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a treatment for Progressive Multiple Sclerosis (PMS), a type of multiple sclerosis where symptoms gradually worsen over time. The treatment being tested is called Ocrelizumab, which is administered as a solution for infusion. The study aims to understand how well this treatment works in managing the disease and ensuring patient safety.

Participants in the study will receive Ocrelizumab over a period of four years. During this time, researchers will monitor the patients to see if there is any progression of the disease and to check for any side effects. The study will also involve regular assessments to evaluate changes in cognitive function, mobility, and overall impact on daily life. These assessments will help determine the effectiveness of the treatment in slowing down or stopping the progression of the disease.

In addition to Ocrelizumab, other medications such as Diphenhydramine Hydrochloride, Paracetamol, and Methylprednisolone may be used as part of the study to manage symptoms or side effects. The study will also include a placebo group to compare the results. The goal is to gather comprehensive data on how Ocrelizumab affects patients with Progressive Multiple Sclerosis and to ensure that the treatment is both effective and safe for long-term use.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of progressive multiple sclerosis (PMS) and ensuring the Expanded Disability Status Scale (EDSS) score is 6.5 or less.

The assessment also checks for documented evidence of disability progression over the past two years, independent of any relapses.

2 baseline evaluation

A baseline evaluation is performed to measure cognitive function and other health parameters. Tests such as the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test – Revised (BVMT-R) are used.

Patient-reported outcomes are collected using various scales, including the Multiple Sclerosis Impact Scale and the Fatigue Scale for Motor and Cognitive function.

3 medication administration

The primary medication, ocrelizumab, is administered as an intravenous (IV) infusion. The dosage is 300 mg, and the infusion is repeated at specified intervals throughout the study.

Additional medications include diphenhydramine hydrochloride (50 mg tablet) and paracetamol (1000 mg oral solution) to manage potential infusion-related reactions.

A methylprednisolone infusion (500 mg) is also administered to reduce the risk of infusion reactions.

4 ongoing assessments

Regular assessments are conducted to monitor the effectiveness and safety of the treatment. This includes tracking changes in cognitive function, disability status, and other health indicators.

MRI scans are performed to evaluate changes in brain volume and lesion characteristics.

5 final evaluation

At the end of the study period, a final evaluation is conducted to assess the overall impact of the treatment on disease progression and patient well-being.

The study aims to determine the proportion of patients with no evidence of progression and no active disease sustained for at least 24 weeks.

Who Can Join the Study?

Must have a confirmed diagnosis of Progressive Multiple Sclerosis (PMS). This is a type of multiple sclerosis where symptoms gradually get worse over time.
Must have an EDSS score of 6.5 or less at the screening. The Expanded Disability Status Scale (EDSS) is a method to measure disability in people with multiple sclerosis.
Must show evidence of disability getting worse over the last 2 years, not related to relapses. A relapse is a sudden worsening of symptoms.
Must meet at least one of the 21 criteria that show disability progression without relapses in the last 2 years, according to a specific checklist used before the study starts.
Must have experience using a smartphone and connecting it to Wi-Fi.
For women who can have children: Must agree to not get pregnant by either not having sex or using birth control during the study and for at least 6 months after the last dose of the study drug.

Who Cannot Join the Study?

Patients who do not have Progressive Multiple Sclerosis (PMS) cannot participate. This is a type of multiple sclerosis where symptoms gradually get worse over time.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not part of the specified clinical trial group cannot participate. This refers to a specific group of patients that the study is focusing on.
Patients who are not either male or female cannot participate. The study includes both male and female participants.
Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Praxis Springub-Schwarz	Westerstede	Germany
University Medicine Greifswald	Greifswald	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
CHU Gabriel-Montpied	Clermont Ferrand	France
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH	Ulm	Germany
Nemocnice Jihlava prispevkova organizace	Jihlava	Czechia
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
DKD HELIOS Klinik Wiesbaden GmbH	Wiesbaden	Germany
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Istituto Neurologico Mediterraneo Neuromed S.p.A.	Pozzilli	Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Rigshospitalet	Copenhagen	Denmark
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
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Npjphmzmunmk As Cju mooi mus Grxb	Stuttgart	Germany
Czkspdj Nkhpfhldlo Khkvfxkuh Sulkqp	Lodz	Poland
Arslvw Uzxmscsovm Hjjyanbb	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	28.05.2018
Denmark	Not recruiting	28.05.2018
France	Not recruiting	28.05.2018
Germany	Not recruiting	28.05.2018
Italy	Not recruiting	28.05.2018
Poland	Not recruiting	28.05.2018
The Netherlands	Not recruiting	28.05.2018

Trial locations

Investigated drugs:

Ocrelizumab is a medication used in this clinical trial to treat patients with progressive multiple sclerosis (PMS). It works by targeting specific cells in the immune system that are believed to contribute to the progression of multiple sclerosis. The goal of using ocrelizumab in this study is to assess its effectiveness and safety over a four-year period in managing the symptoms and progression of PMS.

Investigated diseases:

Progressive Multiple Sclerosis – Progressive multiple sclerosis is a form of multiple sclerosis characterized by a gradual worsening of neurological function over time. Unlike relapsing forms, it does not have distinct relapses or remissions. Symptoms may include increasing difficulty with walking, balance, and coordination, as well as cognitive changes. The disease can affect various parts of the nervous system, leading to a wide range of symptoms. Over time, individuals may experience a steady decline in physical and cognitive abilities. The progression rate can vary significantly from person to person.

Trial ID:

2023-506429-13-00

Protocol code:

MN39159

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Ocrelizumab for Patients with Progressive Multiple Sclerosis

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