Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Relapsing Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the effects of a higher dose of Ocrelizumab in adults with Relapsing Multiple Sclerosis (MS). Multiple Sclerosis is a condition where the immune system mistakenly attacks the protective covering of nerves, which can lead to various neurological problems. The study aims to determine if a higher dose of Ocrelizumab is more effective than the currently approved dose in reducing the progression of disability in people with this type of MS.

Participants in the study will receive either the higher dose of Ocrelizumab, the approved dose, or a placebo. Ocrelizumab is administered as a solution for infusion, which means it is given through a vein. The study will monitor participants over a period to assess the impact of the treatment on their condition. The goal is to see if the higher dose can better prevent the worsening of symptoms compared to the standard dose.

Throughout the study, various health indicators will be tracked, including changes in brain volume, levels of certain proteins in the blood, and the number of specific immune cells. The study will also evaluate the safety of the higher dose by monitoring any side effects. This research is important for understanding how to better manage Relapsing Multiple Sclerosis and improve the quality of life for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a neurological examination.

An MRI scan of the brain is performed to check for abnormalities consistent with multiple sclerosis.

2 baseline evaluation

A baseline evaluation is conducted to establish a starting point for the study. This includes measuring the Expanded Disability Status Scale (EDSS) score, which assesses disability in multiple sclerosis.

Blood samples are taken to measure B-cell levels and other relevant biomarkers.

3 treatment initiation

The treatment phase begins with the administration of ocrelizumab through an intravenous infusion. The dosage is 300 mg, and the infusion is repeated every six months.

Before each infusion, methylprednisolone (500 mg) is administered intravenously to reduce the risk of infusion-related reactions.

Diphenhydramine hydrochloride (50 mg) and paracetamol (500 mg) are taken orally before each infusion to help manage potential side effects.

4 ongoing monitoring

Regular follow-up visits are scheduled to monitor health and response to treatment. These visits include physical examinations and blood tests to measure B-cell levels and other markers.

The study aims to assess the time to onset of confirmed disability progression, which is monitored through various tests and assessments.

5 end of study evaluation

At the end of the study period, a final evaluation is conducted. This includes a comprehensive assessment of disability progression and any changes in brain volume.

The final visit includes a review of any side effects experienced during the study and a summary of the overall health status.

Who Can Join the Study?

Must be between 18 and 55 years old at the time of screening.
Must have a diagnosis of Relapsing Multiple Sclerosis (RMS). This includes Relapsing-Remitting Multiple Sclerosis (RRMS) or Active Secondary Progressive Multiple Sclerosis (aSPMS), where patients still experience relapses. The diagnosis should follow the revised McDonald Criteria from 2017.
Must have had at least two documented clinical relapses in the last 2 years before screening, or one clinical relapse in the year before screening. There should be no relapse 30 days before screening and at the start of the study.
Must be neurologically stable, meaning no significant changes in their neurological condition, for at least 30 days before randomization and baseline assessments.
Must have an Expanded Disability Status Scale (EDSS) score between 0 and 5.5, inclusive, at screening and baseline. The EDSS is a method of measuring disability in people with Multiple Sclerosis.
Must have a documented MRI (Magnetic Resonance Imaging) of the brain showing abnormalities that are consistent with Multiple Sclerosis.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that required treatment with antibiotics or antiviral medications.
Patients who have received any other treatment for Multiple Sclerosis (MS) within a certain period before the study.
Patients who have a history of severe allergic reactions to any medications.
Patients who have participated in another clinical trial within a certain period before this study.
Patients who have a history of drug or alcohol abuse.
Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Universitaet Leipzig	Leipzig	Germany
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
St. Josef-Hospital	Bochum	Germany
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Hospital Beatriz Angelo	Loures	Portugal
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Ma-Lek Clinical Sp. z o.o.	Katowice	Poland
Euromedis Sp. z o.o.	Szczecin	Poland
Noorderhart	Pelt	Belgium
401 General Military Hospital Of Athens	Athens	Greece
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate	Chieti	Italy
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
DKD HELIOS Klinik Wiesbaden GmbH	Wiesbaden	Germany
Instytut Psychiatrii I Neurologii	Warsaw	Poland
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Istituto Neurologico Mediterraneo Neuromed S.p.A.	Pozzilli	Italy
Neurocentrum Bydgoszcz Sp. z o.o.	Bydgoszcz	Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Rigshospitalet	Copenhagen	Denmark
Hospital Alvaro Cunqueiro	Vigo	Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Neuroprotect Sp. z o.o.	Warsaw	Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Groupement Des Hopitaux De L’Institut Catholique De Lille	lomme	France
EMC Instytut Medyczny S.A.	Poznan	Poland
Centrum Neurologii Krzysztof Selmaj	Lodz	Poland
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Nlzqjjntmarq Chtmzq Oj Lmgqax Icbgqgsb Dd Nuogiacscouq O Ir Bfjpk Nusbuv Iocettft Dq Nfvtbzzliwlq Saigcm	Rome	Italy
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Hfuoadsu Vcua dolxfpxm	Barcelona	Spain
Siodpntul Kcae	Budapest	Hungary
Hntvaplm Uddijchkufyrk dh A Chafop	A Coruna Galicia	Spain
Ugr Mypwcgg Tnkrol Ksdy	Budapest	Hungary
Iilprzlblpbd Pekmikdk Lsefonrp Pccyo df hbpy nm mpfo Kkqjcc Rflcas	Lublin	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	26.11.2020
Denmark	Not recruiting	26.11.2020
France	Not recruiting	26.11.2020
Germany	Not recruiting	26.11.2020
Greece	Not recruiting	26.11.2020
Hungary	Not recruiting	26.11.2020
Italy	Not recruiting	26.11.2020
Poland	Not recruiting	26.11.2020
Portugal	Not recruiting	26.11.2020
Spain	Not recruiting	26.11.2020

Trial locations

Investigated drugs:

Ocrelizumab is a medication used in this clinical trial to treat adults with relapsing multiple sclerosis. The study aims to compare the effects of a higher dose of ocrelizumab with the currently approved dose. The goal is to see if the higher dose can better reduce the risk of disability progression in patients.

Relapsing Multiple Sclerosis – Relapsing Multiple Sclerosis (MS) is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by episodes of new or worsening neurological symptoms, known as relapses, followed by periods of partial or complete recovery. These relapses can involve symptoms such as fatigue, difficulty walking, numbness, and vision problems. Over time, the disease can lead to a gradual decline in neurological function. The progression of the disease varies among individuals, with some experiencing frequent relapses and others having long periods of stability. The exact cause of MS is unknown, but it is believed to involve an abnormal immune response that damages the protective covering of nerve fibers.

Trial ID:

2023-506467-34-00

Protocol code:

BN42082

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Relapsing Multiple Sclerosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?