Study on the Effectiveness and Safety of Ocrelizumab, Methylprednisolone, and Diphenhydramine Hydrochloride in Patients with Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a medication called Ocrelizumab in patients with Multiple Sclerosis (MS). Multiple Sclerosis is a condition that affects the brain and spinal cord, leading to a range of symptoms such as problems with vision, arm or leg movement, sensation, or balance. The study involves patients who have previously participated in a related clinical trial sponsored by the pharmaceutical company Roche.

The purpose of this study is to evaluate how well Ocrelizumab works in managing MS symptoms and its safety over time. Participants will receive the medication through an intravenous infusion, which means it is administered directly into the bloodstream. The study will monitor various aspects of the disease, including any changes in disability levels, the occurrence of relapses, and overall disease activity. Additionally, the study will use MRI scans to observe changes in the brain that are associated with MS.

Throughout the study, participants will be regularly assessed to track their progress and any side effects they may experience. The study aims to provide valuable information on the long-term use of Ocrelizumab in treating MS, helping to improve understanding of its benefits and risks for patients living with this condition.

1 initial visit and assessment

Upon joining the study, an initial visit is conducted to assess eligibility. This includes a review of medical history and current health status.

A series of tests and evaluations are performed to establish a baseline for the study. These may include physical examinations, neurological assessments, and laboratory tests.

2 treatment initiation

The treatment phase begins with the administration of methylprednisolone 500 mg as a solution for injection or infusion. This is given intravenously to prepare the body for the main treatment.

Following this, diphenhydramine hydrochloride 50 mg tablets are taken orally to help manage potential allergic reactions.

3 ocrelizumab infusion

The main treatment involves the infusion of ocrelizumab 300 mg. This is administered as a solution for infusion through a vein.

The infusion process is monitored closely to ensure safety and manage any immediate side effects.

4 supportive medication

To manage any discomfort or fever, paracetamol 1000 mg is taken orally as needed.

This medication helps in reducing fever and alleviating pain that may occur during the treatment.

5 follow-up visits

Regular follow-up visits are scheduled to monitor progress and assess the effectiveness of the treatment.

These visits include physical examinations, neurological assessments, and possibly additional laboratory tests to track changes in health status.

6 ongoing monitoring

Throughout the study, continuous monitoring is conducted to evaluate the impact of the treatment on multiple sclerosis symptoms.

This includes tracking any changes in disability progression, relapse rates, and overall quality of life.

7 final assessment

At the end of the study period, a final assessment is performed to determine the overall effectiveness and safety of the treatment.

This includes a comprehensive review of all collected data and a final evaluation of health status.

Who Can Join the Study?

The patient must be able to follow the study rules, as judged by the study doctor.
The patient must be eligible to continue into the MN39158/LIBERTO study. This includes women who were pregnant during earlier studies and are still being monitored for safety, based on the study doctor’s decision after assessing the risks and benefits of continuing treatment with ocrelizumab (a medication used to treat MS).
The patient must meet the criteria to receive more treatment with ocrelizumab.
If a patient became pregnant by chance between the last visit of the previous study and the start of this study, confirmed by pregnancy tests, they will enter a safety follow-up immediately and restart treatment after giving birth and finishing breastfeeding, according to the re-treatment criteria.
Women who can become pregnant must agree to either not have sexual intercourse or use an acceptable birth control method during the treatment period and for at least 6 months or longer after the last dose of ocrelizumab, as stated in the local guidelines for the medication.

Who Cannot Join the Study?

Patients who have not been previously enrolled in a Roche sponsored phase IIIb/IV-trial for multiple sclerosis.
Patients with any other significant health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have a history of severe allergic reactions to medications.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients who have received any live vaccines within the last 4 weeks.
Patients with active infections that require treatment.
Patients with a history of cancer, except for certain types of skin cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
CHU Grenoble Alpes	La Tronche	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Region Stockholm – SLSO	Stockholm	Sweden
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Instytut Psychiatrii I Neurologii	Warsaw	Poland
University Medical Center Ljubljana	Ljubljana	Slovenia
Noorderhart	Pelt	Belgium
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Care Clinic Sp. z o.o.	Katowice	Poland
Awpziethe Ulf	Amsterdam	The Netherlands
Covmnr Hzinoyxebj E Umuqfatasgoos Db Cbpthcu Echyfy	Coimbra	Portugal
Atitvxe Unxjpvbecw Hegczwnm	Aalborg	Denmark
Czci Dh Ncrgu	Vandoeuvre Les Nancy	France
Rqcaspudujuyrz	Copenhagen	Denmark
Cewelt Hfvuyheqbh Ukejrwosobnxh Dm Sansz Adwmbnv Ersghs	Porto	Portugal
Uhpytbldro Og Aokquna	Edegem	Belgium
Cyceyk Hjkyltttnhm Uwgybjvzlhqoo Da Neskj	Nimes	France
Cmncwf hgdartzmlgx ujkpcyqxyusdo dd Lwsxm	Liege	Belgium
Cmagsu Haaaqzgxcyl Lxph Siv	Pierre Benite	France
Hsmfd Skrqroffy Hn	Stavanger	Norway
Qmwba Sipqbo Cjqnudknu Hzirtbec &tfldry Sbmzqkkewps Ubrsyrmdio Hscvnasi &zbzgat Vqpdfmn Gnbokbmfsjqhuyivvw	Gothenburg	Sweden
Frltmgjk Nyhzfcygh Thhdeq	Trnava	Slovakia
Chmb Cirjfd Clrzeqr Aecgihdvs Btwas Ayawvbbcfn	Braga	Portugal
Kvc Zshlym	Zagreb	Croatia
Hfn Ssngwh Acyv	Toulon	France
Atsxzdv Ohneuesroolcmzceaflugnocm Pygqbzvbfxo Gd Rqksaxmirzok Mljbk Dv Csncsvp	Catania	Italy
Mgwkgkxioqwn Heaaokjk Fkr Ayxzcf Tmjkjvwbl Io Nwughxsze Aiw Plthmqkaya Svp Nerw Eto	Sofia	Bulgaria
Vgucurff Dvozsewmskelh Kovkgof	Esztergom	Hungary
Mrslwtvgusm Clemzho Dxdeytfqwldqv Mnoutnz Sud z obwj	Cracow	Poland
Mrjc Nsyedznx Hyfjt Hgiokrpo Ezp	Sofia	Bulgaria
Cvauid Hljkirdpzrd Irkhjlhokjlas Dx Pavfdj Srmgy Gczycwd	St Germain En Laye	France
Bbyygcgo Urstnlpmrs Hmnbenkx Cihyhh	Besançon	France
Atvvvx Ukolbcuyff Hcamrwdo	Aarhus	Denmark
Cxtjwf hfwudoqxjua upgmzfuuvjaqr dw Tthwds Idehulqp mdgphxk ddk Mqgmlfnigm siweimtvhuu	La Louviere	Belgium
Jezr Fwiusz Drzbvswec Kezfab Eq Raptmxzaypexuz	Budapest	Hungary
Nkjoepprkewf Blpcpmuwy Sqw z ovco	Bydgoszcz	Poland
Rtfoaj Vuxgrgqgh	Karlstad	Sweden
Aiwlxpr Otnsuotoctixmwlymiqhnwksz Scrl Acjng	Rome	Italy
Cmo Gavgeffpvdzwiyes	Clermont Ferrand	France
Gomvjx Hfzf Zjjhrqyghw	Gouda	The Netherlands
Jlxpwx Bykic Zzysdlftdf Sisymauyd	S-Hertogenbosch	The Netherlands
Udcdfbrqyf Hvcybkws Buywgqstmd	Bratislava	Slovakia
Ulvtclcfhanvr Kyygmewg Cniivl Muprlfz	Maribor	Slovenia
Hhedyrmb Bxscxiu Ahbybc	Loures	Portugal
Unafmjudgpcrog Cquqphl Kcbkojchq Wbcjavisihqtv Ubcbyzbxongv Mtrglmjodd	Warsaw	Poland
Cuvjqr Hvmqwksncbb Gysvrrc	Gonesse	France
Isrnxeqzkznz Pkrskyqq Lahdkukl Pefgv dp hqra na mktt Kehxvq Rpyawt	Lublin	Poland
Ckntcad Ndokienmvs Kyvalqjsb Sizxjt	Lodz	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	27.07.2018
Bulgaria	Not recruiting	27.07.2018
Croatia	Not recruiting	27.07.2018
Denmark	Not recruiting	27.07.2018
France	Not recruiting	27.07.2018
Hungary	Not recruiting	27.07.2018
Italy	Not recruiting	27.07.2018
Norway	Not recruiting	27.07.2018
Poland	Not recruiting	27.07.2018
Portugal	Not recruiting	27.07.2018
Slovakia	Not recruiting	27.07.2018
Slovenia	Not recruiting	27.07.2018
Sweden	Not recruiting	27.07.2018
The Netherlands	Not recruiting	27.07.2018

Trial locations

Investigated Drugs:

Ocrelizumab is a medication used in the treatment of multiple sclerosis (MS), a condition where the immune system mistakenly attacks the protective covering of nerves. This medication works by targeting and reducing certain immune cells in the body that are believed to play a role in the damage caused by MS. By doing so, it helps to slow down the progression of the disease and reduce the frequency of relapses, which are periods when symptoms get worse. In this clinical trial, the effectiveness and safety of ocrelizumab are being evaluated in patients who have already participated in a previous study involving this medication.

Multiple sclerosis (MS) – 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. As the disease progresses, it 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 MS can be unpredictable, with periods of new symptoms or relapses that can last for days or months, followed by periods of remission. Over time, some people with MS may experience a gradual worsening of symptoms and disability.

Trial ID:

2023-506543-41-00

Protocol code:

MN39158

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Ocrelizumab, Methylprednisolone, and Diphenhydramine Hydrochloride in Patients with Multiple Sclerosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?